Safety of Combining Irinotecan With 5-FU Leucovorin/Folinic Acid Oxaliplatin and Docetaxel Chemotherapies

  • End date
    May 20, 2027
  • participants needed
  • sponsor
    University of Chicago
Updated on 20 June 2021
measurable disease
neutrophil count
pancreatic adenocarcinoma
liver metastasis
primary tumor
chemotherapy regimen
administration intravenous


The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).

Condition Carcinoma, Malignant Adenoma, Gastroesophageal Junction Adenocarcinoma, Pancreatic Adenocarcinoma, Advanced Malignancies, Adenocarcinoma of the Gastroesophageal Junction, adenocarcinomas, Adenocarcinoma, Vulvar Dysplasia and Carcinoma
Treatment docetaxel, Irinotecan, Oxaliplatin, Leucovorin, 5-fluorouracil
Clinical Study IdentifierNCT04361708
SponsorUniversity of Chicago
Last Modified on20 June 2021


Yes No Not Sure

Inclusion Criteria

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
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
Age greater than or equal to 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =1
Life expectancy > 3 months
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 =
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
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

Prior radiation therapy for any cancer
Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met
Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
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
Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0
Documented brain metastases
Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment
Active uncontrolled bleeding
Pregnancy or breastfeeding
Major surgery within 4 weeks
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
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