Pancreatic Cancer Clinical Trial
Official title:
Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
cells. It is not yet known whether giving both of these drugs on the same day is more
effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine
and oxaliplatin to compare how well they work in treating patients with metastatic
pancreatic cancer.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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