Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
6 weeks
No
Viviane Hess, MD
Principal Investigator
University Hospital, Basel, Switzerland
Switzerland: Swissmedic
EK-Nr. 92/05
NCT00744640
October 2005
December 2009
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