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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

Phase 2
18 Years
Not Enrolling
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

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Trial Information

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

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed unresectable or metastatic biliary tract
carcinoma (extrahepatic, intrahepatic, or ampulla of Vater) or gallbladder carcinoma Not
amenable to combined chemotherapy and radiotherapy CNS metastases that are locally
treatable (i.e., lesions treatable with surgery or radiotherapy) allowed if no evidence of
progression for at least 4 weeks after completion of treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 times upper limit of normal
(ULN) AST no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No other malignancy within the past 5 years except basal cell or squamous
cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic or
immunologic therapy No prior biologic or immunologic therapy for metastatic disease No
concurrent immunotherapy No colony stimulating factors administered concurrently with
first course of study therapy, or within 24 hours prior to subsequent courses
Chemotherapy: See Disease Characteristics No prior gemcitabine No prior chemotherapy for
metastatic disease At least 6 months since prior chemotherapy used as radiosensitization
either in the adjuvant setting or for locally advanced disease No other concurrent
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No
prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: See
Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms



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