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

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.

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