Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
- Compare the objective response rate in patients with metastatic adenocarcinoma of the
pancreas treated with two different schedules of gemcitabine hydrochloride and
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the
participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and
oxaliplatin IV over 2 hours on day 2.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by
oxaliplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Objective response rate
Christophe Louvet, MD, PhD
Hopital Saint Antoine
United States: Federal Government