Protocol Index	

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OP RESEARCH PRO00038285 / NALIRIFOX SCREENING DAYS -28 TO -7	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, BASELINE, ADVANCED SMALL INTESTINE AND APPENDICEAL CANCER

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	After consenting  , subjects must meet the following parameters:
·Male or female >= 18 years of age
·Histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer
·Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
·ECOG 0 or 1
·Life Expectancy >=6 months
·Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Exclusion Criteria:
·Hematology laboratory values of:
·Absolute neutrophil count <=2000 cells/mm³
·Platelets <=100,000 cells/mm³
·Hemoglobin <=9 g/dl
·White Blood count <=3000 cells/mm³
·Hepatic laboratory values of aspartate transaminase or alanine aminotransferase
·>5x upper limits of normal if the documented history of hepatic metastases or
·>2.5x upper limit of normal if no liver metastases are present
·Total bilirubin >1.5x ULN OR >1.5 mg/dL.
·PT/INR >1.5x ULN (Note:  patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits
·	Serum creatinine or serum urea >1.5x ULN
·	Estimated GFR rate <50 mL/min
·	Positive pregnancy test, pregnancy, or breastfeeding (female patients only)
·	Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.
·	Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:
a. Arrhythmia
b. Bradycardia
c. Tachycardia
d. Symptomatic valvular disease
e. Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV
f. Unstable angina pectoris.
·	Myocardial infarction in the last 6 months
·	Active bleeding diathesis.
·	Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months.
·	Receiving chronic treatment of corticosteroids >=5 mg of prednisone per day or another immunosuppressive agents
·	Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.
·	History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.
·	History of malignancy or active treatment for malignancy (i.e., radiation or chemotherapy, including monoclonal antibodies) within 5 years. Note: Patients with squamous or basal cell carcinomas of the skin, carcinomas in situ of the cervix or uterus, ductal breast cancer in situ, resected low-grade prostate cancer, or other malignancies that in the opinion of the investigator are considered cured may participate.
·	Receipt of live, attenuated vaccine or close contact with someone who has received a live, attenuated vaccine within the patpast 1 month (Influenza vaccine will be allowed if administered >21 days)
·	Receipt of any investigational agent or study treatment within the past 30 days.
·	Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months.
·	Allergies reaction to irinotecan or liposomal irinotecan. 21. Use of strong inhibitors/inducers of CYP3A, CYP2C8 and UGT1A1
·	Presence of any contraindications outlines in IB/USPI Onivyde or USPI 5-FU, LV or Oxaliplatin
·	History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical Exam [includes vital signs (blood pressure, oral temperature, pulse, and respiratory rate) measurements]
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Collection of Archived Tissue
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Tissue biopsy (optional)