Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
OBJECTIVES:
Primary
- Compare the objective response rate in patients with metastatic adenocarcinoma of the
pancreas treated with two different schedules of gemcitabine hydrochloride and
oxaliplatin.
Secondary
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these
regimens.
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
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Objective response rate
No
Christophe Louvet, MD, PhD
Study Chair
Hopital Saint Antoine
United States: Federal Government
CDR0000453849
NCT00268411
September 2004
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