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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.
- 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
- to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
- Phase I: Dose-limiting toxicity
- Phase II: Objective tumor response
- 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
Locally Advanced Pancreatic Cancer
gemcitabine, oxaliplatin, capecitabine
Cantonal Hospital Bruderholz
University Hospital, Basel, Switzerland
Published on BioPortfolio: 2014-07-24T14:16:02-0400
RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and...
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whethe...
This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipat...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Ph...
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