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Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

NCT00744640 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2010-01-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

gemcitabine, oxaliplatin, capecitabine

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

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Swiss Cancer League

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Viviane Hess, MD · University Hospital, Basel, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-02-28
Completion
2009-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00744640 on ClinicalTrials.gov