Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00268411
- 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 the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.
Secondary
* Compare the clinical benefits and tolerability of these regimens in these patients.
* Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
* Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Clinical benefits and tolerability Progression-free and overall survival
Trial Locations
- Locations (15)
Polyclinique des Quatre Pavillons
🇫🇷Lormont, France
Hopital Duffaut
🇫🇷Avignon, France
Hopital Tenon
🇫🇷Paris, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Hopital Saint - Louis
🇫🇷La Rochelle, France
Hopital Louis Pasteur - Le Coudray
🇫🇷Le Coudray, France
C.H. Senlis
🇫🇷Senlis, France
Clinique Saint Jean
🇫🇷Lyon, France
Hopital Drevon
🇫🇷Dijon, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Polyclinique De Courlancy
🇫🇷Reims, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Centre Hospitalier de Dreux
🇫🇷Dreux, France
Hopital Saint Antoine
🇫🇷Paris, France
Clinique Victor Hugo
🇫🇷Le Mans, France