MedPath

Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

Phase 2
Conditions
Extrahepatic Bile Duct Cancer
Pancreatic 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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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

Scroll for more (40 remaining)
Clinique De Rochebelle
🇫🇷Ales, France

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.