Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

Phase 3

• Conditions: Pancreatic Cancer

• Registration Number: NCT00075452
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

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 whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Detailed Description

OBJECTIVES:

Primary

* Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.

Secondary

* Compare the time of response in patients treated with these regimens.

* Compare the clinical benefit of and tolerance to these regimens in these patients.

* Compare the quality of life of patients treated with these regimens.

* Compare the progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

Quality of life is assessed at baseline and then every 2 months.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-01-09
• Study First Submitted QC: 2004-01-11
• Study First Posted: 2004-01-12
• Status Verified: 2007-05
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Quality of life
Progression-free survival
Time to response
Clinical benefit

Trial Locations

Locations (38)

Centre Paul Papin; 🇫🇷 Angers, France

C.H.G. Beauvais; 🇫🇷 Beauvais, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

CHU Ambroise Pare; 🇫🇷 Boulogne Billancourt, France

CMC Bligny; 🇫🇷 Briis Sous Forges, France

Hopital Louis Pasteur; 🇫🇷 Chartres, France

Chu-Hopital Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

Hopital Beaujon; 🇫🇷 Clichy, France

Hopital Louis Mourier; 🇫🇷 Colombes, France

Hopital Drevon; 🇫🇷 Dijon, France

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