Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00004884
- 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. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.
- Detailed Description
OBJECTIVES: I. Assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin in patients with metastatic or locoregionally advanced pancreatic cancer. II. Assess the toxicity, response rate, duration of response, time to progression, survival, performance status, and weight associated with these treatment regimens in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patents are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Arm II: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment is repeated every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression, and then every 8 weeks until death.
PROJECTED ACCRUAL: Up to 82 patients (41 per arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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 (19)
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Praxis Innere Medizin
🇩🇪Neustadt, Germany
Klinikum St. Marien
🇩🇪Amberg, Germany
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Institut Gustave Roussy
🇫🇷Villejuif, France
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
CHU Ambroise Pare
🇫🇷Boulogne Billancourt, France
Marien Hospital
🇩🇪Hagen, Germany
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Universitaetsklinik und Strahlenklinik - Essen
🇩🇪Essen, Germany
Institut Jules Bordet
🇧🇪Brussels, Belgium
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
Dokuz Eylul University School of Medicine
🇹🇷Izmir, Turkey
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Hermann-Holthusen Institute for Radiotherapy
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum der Universitaet Ulm
🇩🇪Ulm, Germany
Saint Laurentius Ziekenhuis
🇳🇱Roermond, Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland