NCT00744640

Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Locally Advanced Pancreatic Cancer
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine, oxaliplatin, capecitabine	gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-02-01
• Completion: 2009-12-01
• First posted: 2008-09-01
• Last updated: 2010-01-12

Locations

8 sites across 1 country: Switzerland