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RESEARCH PRO00020925 ABDELRAHIM ASTELLAS PH3 GLOW	

Types:      Research Oncology Treatment
Synonyms:  20925, PRO20925, CLDN, CLDN +, CLAUDIN, CAPOX, XELODA, CAPECITABINE, OXALIPLATIN, ELOXATIN, ZOLBETUXIMAB, IMAB362, GEJ, ADENOCARCINOMA

Screening / Baseline	Repeat 1 time	Cycle length: 45 days	Within Day –45 to Day –1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Full Physical Exam
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --				Within 28 days prior to Cycle 1 Day 1	Perform every 1 day x1		Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	o Bone scans (or focal X-ray) or brain imaging should be performed if metastatic disease in bone or brain is suspected, respectively. 
o The same mode of imaging should be utilized throughout the study unless medical necessity requires a change. 
o Please order scans as appropriate.
				Within 14 days prior to Cycle 1 Day 1	Perform every 1 day x1		Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		  	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Dihydropyrimidine dehydrogenase (DPD) testing
			Take-Home Medications Prior to Treatment
  	capecitabine (XELODA) 500 mg chemo tablet	Dose: 1,000 mg/m2	Route: oral	2 times daily after meals	Dispense: --	Refills: --	Start: S			Instructions:	On days 1 to 14 of each cycle.		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	o Capecitabine can be continued beyond 8 cycles based on Physician's judgment. 
o Day 1 dose should be administered at site under research staff supervision.
					
Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 11	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physical Exam (Only if clinically significant changes from Screening are observed_ at PI discretion)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected prior to pharmacokinetic samples/ prior to every oxaliplatin infusion (before any antiemetic administration)
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Oxaliplatin.		  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Oxaliplatin.		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Oxaliplatin.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	o Administer Zolbetuximab PRIOR to CAPOX.  
o Zolbetuximab infusion should not exceed 6 hours from start of infusion.
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 800 mg/m2 in sodium chloride 0.9% infusion	Dose: 800 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	800 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 15 (+/- 5 minutes) during Zolbetuximab/placebo infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The POST Zolbetuximab/Placebo infusion observation period can be conducted during the CAPOX administration
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	o Following the first dose of Zolbetuximab/Placebo on C1D1, the subject must be observed for 2 hours post zolbetuximab/placebo infusion. 
o If AEs are observed during this time, subsequent Zolbetuximab/Placebo infusion times should be extended and subjects should continue to be observed for 2 hours post zolbetuximab/placebo infusion. 
o If the subject does not develop any AEs, the subject should be observed for 1hour post-infusion for their subsequent Zolbetuximab/Placebo infusions.
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	o Administer CAPOX AFTER Zolbetuximab/Placebo infusion. 
o ECG and labs (potassium, magnesium, and calcium) must be within normal limits prior to every Oxaliplatin infusion.
			Chemotherapy
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Perform prior to every Oxaliplatin infusion.
		  	OXALIplatin (ELOXATIN) 130 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 130 mg/m2	Route: intravenous	once over 120 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	Irritant - avoid extravasation. Flush line with D5W before and after oxaliplatin infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	OXALIPLATIN 100 MG/20 ML INTRAVENOUS SOLUTION	Medications	130 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected upon completion of every Oxaliplatin infusion
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	o Day 1 dose of Capecitabine should be administered at site under research staff supervision.  
o In case the first dose of Capecitabine on day 1 of a cycle is administered too late in the day for the second dose to be administered on the same day, the last dose of that cycle should be taken in the morning of day 15. 
o Capecitabine should be taken within 30 minutes after a meal.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for Oxaliplatin.		☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 11	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected prior to pharmacokinetic samples/ prior to every oxaliplatin infusion (before any antiemetic administration)
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Oxaliplatin.		  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Oxaliplatin.		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Oxaliplatin.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	o Administer Zolbetuximab PRIOR to CAPOX.  
o Zolbetuximab infusion should not exceed 6 hours from start of infusion.
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 15 (+/- 5 minutes) during Zolbetuximab/placebo infusion
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The POST Zolbetuximab/Placebo infusion observation period can be conducted during the CAPOX administration
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	o Administer CAPOX AFTER Zolbetuximab/Placebo infusion. 
o ECG and labs (potassium, magnesium, and calcium) must be within normal limits prior to every Oxaliplatin infusion.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Perform prior to every Oxaliplatin infusion.
			Chemotherapy
  	OXALIplatin (ELOXATIN) 130 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 130 mg/m2	Route: intravenous	once over 120 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	Irritant - avoid extravasation. Flush line with D5W before and after oxaliplatin infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	OXALIPLATIN 100 MG/20 ML INTRAVENOUS SOLUTION	Medications	130 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected upon completion of every Oxaliplatin infusion
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for Oxaliplatin.		☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 11	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected prior to pharmacokinetic samples/ prior to every oxaliplatin infusion (before any antiemetic administration)
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Oxaliplatin.		  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Oxaliplatin.		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Oxaliplatin.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	o Administer Zolbetuximab PRIOR to CAPOX.  
o Zolbetuximab infusion should not exceed 6 hours from start of infusion.
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The POST Zolbetuximab/Placebo infusion observation period can be conducted during the CAPOX administration
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	o Administer CAPOX AFTER Zolbetuximab/Placebo infusion. 
o ECG and labs (potassium, magnesium, and calcium) must be within normal limits prior to every Oxaliplatin infusion.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Perform prior to every Oxaliplatin infusion.
			Chemotherapy
  	OXALIplatin (ELOXATIN) 130 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 130 mg/m2	Route: intravenous	once over 120 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	Irritant - avoid extravasation. Flush line with D5W before and after oxaliplatin infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	OXALIPLATIN 100 MG/20 ML INTRAVENOUS SOLUTION	Medications	130 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected upon completion of every Oxaliplatin infusion
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for Oxaliplatin.		☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 11	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected prior to pharmacokinetic samples/ prior to every oxaliplatin infusion (before any antiemetic administration)
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Oxaliplatin.		  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Oxaliplatin.		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Oxaliplatin.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	o Administer Zolbetuximab PRIOR to CAPOX.  
o Zolbetuximab infusion should not exceed 6 hours from start of infusion.
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The POST Zolbetuximab/Placebo infusion observation period can be conducted during the CAPOX administration
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	o Administer CAPOX AFTER Zolbetuximab/Placebo infusion. 
o ECG and labs (potassium, magnesium, and calcium) must be within normal limits prior to every Oxaliplatin infusion.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Perform prior to every Oxaliplatin infusion.
			Chemotherapy
  	OXALIplatin (ELOXATIN) 130 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 130 mg/m2	Route: intravenous	once over 120 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	Irritant - avoid extravasation. Flush line with D5W before and after oxaliplatin infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	OXALIPLATIN 100 MG/20 ML INTRAVENOUS SOLUTION	Medications	130 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected upon completion of every Oxaliplatin infusion
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for Oxaliplatin.		☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycles 5,6	Repeat 2 times	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 11	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected prior to pharmacokinetic samples/ prior to every oxaliplatin infusion (before any antiemetic administration)
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Oxaliplatin.		  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Oxaliplatin.		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Oxaliplatin.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	o Administer Zolbetuximab PRIOR to CAPOX.  
o Zolbetuximab infusion should not exceed 6 hours from start of infusion.
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The POST Zolbetuximab/Placebo infusion observation period can be conducted during the CAPOX administration
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	o Administer CAPOX AFTER Zolbetuximab/Placebo infusion. 
o ECG and labs (potassium, magnesium, and calcium) must be within normal limits prior to every Oxaliplatin infusion.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Perform prior to every Oxaliplatin infusion.
			Chemotherapy
  	OXALIplatin (ELOXATIN) 130 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 130 mg/m2	Route: intravenous	once over 120 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	Irritant - avoid extravasation. Flush line with D5W before and after oxaliplatin infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	OXALIPLATIN 100 MG/20 ML INTRAVENOUS SOLUTION	Medications	130 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected upon completion of every Oxaliplatin infusion
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for Oxaliplatin.		☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 11	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected prior to pharmacokinetic samples/ prior to every oxaliplatin infusion (before any antiemetic administration)
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Oxaliplatin.		  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Oxaliplatin.		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Oxaliplatin.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	o Administer Zolbetuximab PRIOR to CAPOX.  
o Zolbetuximab infusion should not exceed 6 hours from start of infusion.
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The POST Zolbetuximab/Placebo infusion observation period can be conducted during the CAPOX administration
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	o Administer CAPOX AFTER Zolbetuximab/Placebo infusion. 
o ECG and labs (potassium, magnesium, and calcium) must be within normal limits prior to every Oxaliplatin infusion.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Perform prior to every Oxaliplatin infusion.
			Chemotherapy
  	OXALIplatin (ELOXATIN) 130 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 130 mg/m2	Route: intravenous	once over 120 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	Irritant - avoid extravasation. Flush line with D5W before and after oxaliplatin infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	OXALIPLATIN 100 MG/20 ML INTRAVENOUS SOLUTION	Medications	130 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected upon completion of every Oxaliplatin infusion
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for Oxaliplatin.		☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 11	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected prior to pharmacokinetic samples/ prior to every oxaliplatin infusion (before any antiemetic administration)
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with Oxaliplatin.		  	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for Oxaliplatin.		  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.  Do NOT administer with Oxaliplatin.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	o Administer Zolbetuximab PRIOR to CAPOX.  
o Zolbetuximab infusion should not exceed 6 hours from start of infusion.
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The POST Zolbetuximab/Placebo infusion observation period can be conducted during the CAPOX administration
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	o Administer CAPOX AFTER Zolbetuximab/Placebo infusion. 
o ECG and labs (potassium, magnesium, and calcium) must be within normal limits prior to every Oxaliplatin infusion.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Perform prior to every Oxaliplatin infusion.
			Chemotherapy
  	OXALIplatin (ELOXATIN) 130 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 130 mg/m2	Route: intravenous	once over 120 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	Irritant - avoid extravasation. Flush line with D5W before and after oxaliplatin infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	OXALIPLATIN 100 MG/20 ML INTRAVENOUS SOLUTION	Medications	130 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected upon completion of every Oxaliplatin infusion
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for Oxaliplatin.		☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 7	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected if clinically indicated and/or per local requirements only
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Zolbetuximab infusion should not exceed 6 hours from start of infusion
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	o Subjects may continue to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion. 
o If continue, verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 7	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected if clinically indicated and/or per local requirements only
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Zolbetuximab infusion should not exceed 6 hours from start of infusion
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	o Subjects may continue to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion. 
o If continue, verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 7	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected if clinically indicated and/or per local requirements only
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Zolbetuximab infusion should not exceed 6 hours from start of infusion
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	o Subjects may continue to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion. 
o If continue, verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 12	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 7	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed PRE-dose
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Physical Exam - Targeted (symptom driven)
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Should be collected if clinically indicated and/or per local requirements only
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		☑	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		☐	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Order only IF clinically indicated and/or per local requirements
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	ondansetron (ZOFRAN) IV	Dose: --	Route: intravenous	once for 1 dose	Start: S				☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				☑	prochlorperazine (COMPAZINE) tablet	Dose: --	Route: oral	once for 1 dose					☑	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours PRN	Start: S				☑	hydrocortisone sodium succinate (Solu-CORTEF) injection	Dose: --	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Zolbetuximab infusion should not exceed 6 hours from start of infusion
		  	INV-Zolbetuximab/Placebo (GLOW/Pro00020925/Abdelrahim) 600 mg/m2 in sodium chloride 0.9% infusion	Dose: 600 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared bag may contain active Zolbetuximab or placebo in a blinded manner. Administer intravenously using tubing with attached 0.2micron inline filter. Rate: 0-30 minutes: *** ml/hour;  if tolerated, then for 30-60 minutes: *** mL/hour;   if tolerated, then rest of the infusion at *** mL/hour.  Dose may be adjusted based on patient tolerating infusion. Do Not Shake.  Stability of prepared dose: 6 hours at room temperature/24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ZOLBETUXIMAB/PLACEBO 20 MG/ML INTRAVENOUS SOLN (GLOW/PRO00020925/ABDELRAHIM)	Medications	600 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	 	Yes	Yes			  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Every 30 (+/-10) minutes during Zolbetuximab/Placebo infusion if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1
			Nursing Orders
☑	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	o The subject should be instructed to notify site personnel if they develop any AEs during this observation time period.
		☑	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	o In the event of grade 3 or 4 IRRs post zolbetuximab/placebo infusion, samples for cytokine/chemokine and tryptase should be collected.
			Labs
☐	MISCELLANEOUS REFERRAL TEST	Interval: --	Occurrences: --	Comments:	Cytokine/ Chemokine - in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
		☐	TRYPTASE	Interval: --	Occurrences: --	Comments:	Order ONLY in the event of grade 3 or 4 IRRs post Zolbetuximab/Placebo infusion
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform every 30 (+/-10) minutes post Zolbetuximab/Placebo infusion during Post-infusion Observation Period (1 hour only if subject did not develop any AEs during the Post-infusion Observation Period of Cycle 1)
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	o Subjects may continue to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion. 
o If continue, verify patient has taken Capecitabine as instructed.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Study Treatment Discontinuation Visit 	Repeat 1 time	Cycle length: 23 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Visit will take place LESS than or EQUAL to 7 days following the decision to discontinue study treatment (Zolbetuximab/Placebo and CAPOX [both components])
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	If Zolbetuximab/Placebo and CAPOX (both components) are discontinued on a different day, subjects will have separate Study Treatment Discontinuation Visits following each treatment's discontinuation
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
30-Day Safety Follow-up Visit (+7 days)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	A 30-Day Safety Follow-up Visit should occur 30 days after the last dose of Zolbetuximab/Placebo
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	A 30-Day Safety Follow-up Visit should occur 30 days after the last dose of CAPOX (both components) and may be conducted by phone if the subject is unable to visit the site and will require contact for AE/SAE collection only.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Only for female of childbearing potential
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --