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
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.
PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study within 1 to 2.5
years.
Interventional
Primary Purpose: Treatment
Steven R. Alberts, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068421
NCT00009893
May 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |
Medcenter One Health System | Bismarck, North Dakota 58501 |