Metastatic Pancreatic Cancer Clinical Trial
Official title:
Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.
Primary Objectives:
- Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination
with gemcitabine and capecitabine (GEMOXEL) in patients with APC
- Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC
Secondary Objectives:
- to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
Primary Endpoints:
- Phase I: Dose-limiting toxicity
- Phase II: Objective tumor response
Secondary Endpoints:
- Toxicity at MTD according to NCI CTC 3.0
- Progression-free survival and Overall Survival
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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