OncoMatch/Clinical Trials/NCT04361708
Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
Is NCT04361708 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for pancreatic adenocarcinoma.
Treatment: Oxaliplatin · Docetaxel · Leucovorin · Irinotecan · 5-Fluorouracil — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Pancreatic Cancer
Gastric Cancer
Esophageal Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Prior radiation therapy for any cancer
Cannot have received: chemotherapy for metastatic disease
Exception: Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met
Prior chemotherapy for metastatic disease
Lab requirements
Blood counts
Absolute neutrophil count (ANC) = 1500/uL; Hemoglobin > 9g/dL (transfusion permitted with stability for > 1 week); Platelets > 100,000/uL
Kidney function
Creatinine = 1.5 mg/dL
Liver function
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.
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Chicago · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04361708 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages