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.

Condition	Treatment or Intervention	Phase
recurrent adult primary liver cancer advanced adult primary liver cancer recurrent gallbladder cancer unresectable gallbladder cancer localized unresectable adult primary liver cancer recurrent extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer	Procedure: chemotherapy  Drug: fluorouracil  Drug: gemcitabine  Drug: leucovorin calcium	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic Jacksonville, Jacksonville,  Florida,  32224,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Steven R. Alberts,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000068421; NCCTG-N0042
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00009893
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08