Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
- Compare the objective response rate in patients with metastatic adenocarcinoma of the
pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs
gemcitabine as first-line chemotherapy. (Phase II)
- Compare the survival of patients treated with these regimens. (Phase III)
- Compare the toxicity of these regimens in these patients.
- Compare progression-free survival of patients treated with these regimens. (Phase III)
- Compare the overall response rate in patients treated with these regimens. (Phase III)
- Compare quality of life of patients treated with these regimens. (Phase III)
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours,
leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and
fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14
- Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning
on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and
71). Courses repeat every 28 days.
PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be
accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Objective response rate (Phase II)
Thierry Conroy, MD
Centre Alexis Vautrin
United States: Federal Government