Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
- Conditions
- Extrahepatic Bile Duct CancerPancreatic Cancer
- Registration Number
- NCT00010088
- 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 combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.
- Detailed Description
OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit, in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this regimen in this patient population. III. Determine the survival without disease progression in patients treated with this regimen. IV. Determine the overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or may undergo surgical resection. Fluorouracil-based chemotherapy (with or without radiotherapy) may then resume after surgery. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 14-39 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 (50)
Clinique De Rochebelle
🇫🇷Ales, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Centre D'Oncologie Du Pays-Basqu
🇫🇷Bayonne, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Institut Bergonie
🇫🇷Bordeaux, France
CMC Bligny
🇫🇷Briis Sous Forges, France
Clinique Saint-Jean
🇫🇷Cagne-sur-Mer, France
Hopital Fontenoy
🇫🇷Chartres, France
Hopital Beaujon
🇫🇷Clichy, France
Hopital Drevon
🇫🇷Dijon, France
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