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

Phase 2

Completed

• Conditions: Liver Cancer; Extrahepatic Bile Duct Cancer; Gallbladder Cancer
• Interventions: Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: leucovorin calcium

• Registration Number: NCT00009893
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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

Detailed 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 Timeline

• Study First Submitted: 2001-02-02
• Study Start: 2001-05
• Study First Submitted QC: 2003-12-31
• Study First Posted: 2004-01-01
• Primary Completion: 2005-01
• Study Completion: 2009-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine + leucovorin + fluorouracil	leucovorin calcium	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.
gemcitabine + leucovorin + fluorouracil	gemcitabine hydrochloride	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.
gemcitabine + leucovorin + fluorouracil	fluorouracil	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.

Primary Outcome Measures

Name	Time	Method
survival at 6 months	at 6 months

Secondary Outcome Measures

Name	Time	Method
overall survival	Up to 5 years
tumor response rate	Up to 5 years

Trial Locations

Locations (19)

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

Medcenter One Health System; 🇺🇸 Bismarck, North Dakota, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CCOP - Toledo Community Hospital Oncology Program; 🇺🇸 Toledo, Ohio, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Metro-Minnesota; 🇺🇸 Saint Louis Park, Minnesota, United States

CCOP - Duluth; 🇺🇸 Duluth, Minnesota, United States

CentraCare Clinic; 🇺🇸 Saint Cloud, Minnesota, United States

CCOP - Merit Care Hospital; 🇺🇸 Fargo, North Dakota, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States

CCOP - Ann Arbor Regional; 🇺🇸 Ann Arbor, Michigan, United States

CCOP - Missouri Valley Cancer Consortium; 🇺🇸 Omaha, Nebraska, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States