Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00006117
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. II. Determine the tolerablility and clinical benefit of this regimen in these patients. III. Evaluate the progression free survival and the overall survival of these patients when treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5 hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Hopital Beaujon
🇫🇷Clichy, France
Institut Jules Bordet
🇧🇪Brussels, Belgium
American Hospital of Paris
🇫🇷Neuilly Sur Seine, France
Polyclinique De Courlancy
🇫🇷Reims, France
Clinique Saint Jean
🇫🇷Lyon, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Centre Paul Papin
🇫🇷Angers, France
Hopital Drevon
🇫🇷Dijon, France
Hopital Tenon
🇫🇷Paris, France
Hopital Saint Antoine
🇫🇷Paris, France