744640
Last Update Posted: 2010-01-12
Recruiting has ended
All Genders accepted | 18 Years + |
46 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
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
Eligibility
Relevant conditions:
Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov