Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00030732
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine.
* Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration.
Patients are followed every 9 weeks.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 319
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Gemcitabine alone Gemcitabine alone Gemcitabine alone Gemcitabine + Capecitabine Gemcitabine + Capecitabine Gemcitabine + Capecitabine
- Primary Outcome Measures
Name Time Method Gemcitabine + Capecitabine vs. Gemcitabine alone 8 weeks To compare survival, efficacy, quality of life and toxicity between the combination therapy (Capecitabine and Gemcitabine) and the monotherapy (Gemcitabine alone) in advanced pancreatic cancer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
Saint Claraspital AG
🇨ðŸ‡Basel, Switzerland
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Spitalzentrum Biel
🇨ðŸ‡Biel, Switzerland
Ratisches Kantons und Regionalspital
🇨ðŸ‡Chur, Switzerland
Hopital Cantonal Universitaire de Geneve
🇨ðŸ‡Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
City Hospital Triemli
🇨ðŸ‡Zurich, Switzerland
Oncology Institute of Southern Switzerland
🇨ðŸ‡Zurich, Switzerland
UniversitaetsSpital
🇨ðŸ‡Zurich, Switzerland
Institut Central des Hopitaux Valaisans
🇨ðŸ‡Sion, Switzerland
Universitatsspital-Basel
🇨ðŸ‡Basel, Switzerland
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Vienna, Austria
Regionalspital
🇨ðŸ‡Thun, Switzerland