A Phase 1/2 interventional study of gemcitabine, oxaliplatin, capecitabine in Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, sponsored by University Hospital, Basel, Switzerland. Completed at 8 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-12.
Sponsored by University Hospital, Basel, Switzerland · Phase 1/2, Interventional, and Treatment
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:
Secondary Objectives:
Primary Endpoints:
Secondary Endpoints:
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 46 is close to the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
single arm study with triple combination chemotherapy
Drug: gemcitabine, oxaliplatin, capecitabine
gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks
Response rate
Time frame: 6 weeks
Progression-free survival and overall survival
Time frame: 3 months
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland