Spots Global Cancer Trial Database for Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

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Trial Identification

Brief Title: Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

Official Title: Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study

Study ID: NCT00744640

Conditions

Locally Advanced Pancreatic Cancer

Metastatic Pancreatic Cancer

Interventions

gemcitabine, oxaliplatin, capecitabine

Study Description

Brief Summary: 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.

Detailed Description: 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