Actively Recruiting
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
Led by University of Chicago · Updated on 2025-10-01
54
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastroesophageal adenocarcinoma, cholangiocarcinoma, gallbladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary suspected to be upper GI, or other primary GI malignancy suitable for I-FLOAT
- History of obstructive jaundice due to primary tumor must be resolved to less than 1.5 times upper limit of normal with a metal biliary stent in place
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 1
- Life expectancy greater than 3 months
- Adequate organ function including ANC ≥1500/uL, hemoglobin >9 g/dL (stable for >1 week if transfused), platelets >100,000/uL, total bilirubin ≤1.5 mg/dL, AST and ALT ≤2.5 times upper limit (or ≤5 times if hepatic metastases), alkaline phosphatase ≤2.5 times upper limit unless bone metastasis without liver metastasis, creatinine ≤1.5 mg/dL
- Measurable or non-measurable disease allowed
- Women of childbearing potential and sexually active males must use effective contraception during treatment and for 3 months after
- Negative pregnancy test at screening for patients of childbearing potential
- Patients on CYP3A4 substrates, inhibitors, or inducers should switch drugs if possible due to interactions with irinotecan
You will not qualify if you...
- Prior radiation therapy for any cancer
- Prior chemotherapy for metastatic disease, except recurrence within 6 months of perioperative chemotherapy if other criteria met
- Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- Diarrhea grade 1 or higher by NCI-CTCAE v4.0; pancreatic insufficiency patients must be on enzyme replacement
- Neuropathy grade 2 or higher by NCI-CTCAE v4.0
- Documented brain metastases
- Serious underlying medical or psychiatric illnesses increasing risk of complications
- Active uncontrolled bleeding
- Pregnancy or breastfeeding
- Major surgery within 4 weeks
- Previous or concurrent malignancy except certain treated cancers with low recurrence risk and meeting other criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
D
Daniel Catenacci, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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