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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks
Cantonal Hospital Bruderholz
Bruderholz, Basel-Landschaft, Switzerland
Cantonal Hospital Liestal
Liestal, Basel-Landschaft, Switzerland
St. Clara Hospital
Basel, Switzerland
University Hospital Basel
Basel, Switzerland
Cantonal Hospital Lucerne
Lucerne, Switzerland
City Hospital Triemli
Zurich, Switzerland
Oncocenter Hirslanden
Zurich, Switzerland
University Hospital
Zurich, Switzerland
Response rate
Time frame: 6 weeks
Progression-free survival and overall survival
Time frame: 3 months
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