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OncoMatch/Clinical Trials/NCT04361708

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

Is NCT04361708 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for pancreatic adenocarcinoma.

Phase 1RecruitingUniversity of ChicagoNCT04361708Data as of May 2026

Treatment: Oxaliplatin · Docetaxel · Leucovorin · Irinotecan · 5-FluorouracilThe 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).

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Gastric Cancer

Esophageal Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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

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