Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic
adenocarcinoma, gastroesophageal adenocarcinoma, cholangiocarcinoma, gallbladder
adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with upper GI
primary suspected), or other primary GI malignancy for which the treating physician
feels that I-FLOAT is a reasonable therapeutic option.
2. Patients with a history of obstructive jaundice due to the primary tumor must have
resolved to <1.5 X upper limit of normal and a metal biliary stent in place
3. Age greater than or equal to 18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status =1
5. Life expectancy > 3 months
6. Adequate organ function, as defined by each of the following:
Absolute neutrophil count (ANC) = 1500/uL Hemoglobin > 9g/dL (transfusion permitted
with stability for > 1 week) Platelets > 100,000/uL Total bilirubin = 1.5 mg/dL AST
and ALT = 2.5 X upper limit of normal; alkaline phosphatase = 2.5 X upper limit of
normal, unless bone metastasis is present in the absence of liver metastasis.
AST and ALT = 5 X upper limit of normal if hepatic metastases are present. Creatinine
= 1.5 mg/dL
7. Measurable or non-measurable disease will be allowed.
8. Women of childbearing potential and sexually active males must use an effective
contraception method during treatment and for three months after completing treatment.
9. Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing
potential
10. Patients taking substrates, inhibitors, or inducers of CYP3A4 should be encouraged to
switch to alternative drugs whenever possible, given the potential for drug-drug
interactions with irinotecan.
Exclusion Criteria:
1. Prior radiation therapy for any cancer.
2. Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of
perioperative chemotherapy are eligible if other eligibility criteria are met
3. Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
4. Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI-CTCAE, v. 4.0*). Pancreatic cancer patients with
clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme
replacement.
5. Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0.
6. Documented brain metastases
7. Serious underlying medical or psychiatric illnesses that would, in the opinion of the
treating physician, substantially increase the risk for complications related to
treatment.
8. Active uncontrolled bleeding.
9. Pregnancy or breastfeeding.
10. Major surgery within 4 weeks.
11. Previous or concurrent malignancy, except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the
patient has been previously treated and the lifetime recurrence risk is less than 30%,
and meets all other eligibility criteria.
