NCT00010088

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

Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extrahepatic Bile Duct Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil
DRUG	gemcitabine hydrochloride
DRUG	leucovorin calcium
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 1999-01-01
• First posted: 2004-05-20
• Last updated: 2009-02-09

Locations

50 sites across 2 countries: France, Luxembourg