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Gemcitabine

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single arm study with triple combination chemotherapy

gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks

gemcitabine, oxaliplatin, capecitabine

Viviane Hess, MD

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

Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma	NCT00744640	Locally Advance... Metastatic Panc...	gemcitabine, ox...	18 Years -	University Hospital, Basel, Switzerland
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma	NCT00744640	Locally Advance... Metastatic Panc...	gemcitabine, ox...	18 Years -	University Hospital, Basel, Switzerland

Spots Global Cancer Trial Database for gemcitabine, oxaliplatin, capecitabine