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Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

Liver Cancer Clinical Trial

Official title:
Phase II Trial Of Gemcitabine, 5-Fluorouracil, And Leucovorin In Patients With Measurable Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Of Vater) And Gallbladder Carcinoma

Clinical Trial 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 combination chemotherapy in treating patients who have unresectable or metastatic biliary tract or gallbladder cancer.

Clinical Trial Description

OBJECTIVES: I. Determine the 6-month survival and overall survival of patients with unresectable or metastatic biliary tract carcinoma or gallbladder cancer treated with gemcitabine, fluorouracil, and leucovorin calcium. II. Determine the tumor response in these patients treated with this regimen. III. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes followed by leucovorin calcium IV and fluorouracil IV over 5-10 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00009893
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact
Status Completed
Phase Phase 2
Start date May 2001
Completion date October 2009
View Details
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