Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic/hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct)
• •* Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both
• •* Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete
• •Must be able to start treatment within 12 weeks of surgery
• •No pancreatic or periampullary cancer
• •No mucosal gallbladder cancer
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Urea \< 1.5 times upper limit of normal (ULN)
• •Creatinine \< 1.5 times ULN
• •Glomerular filtration rate ≥ 60 mL/min (if \< 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA)
• •Hemoglobin ≥ 10 g/dL
• •WBC ≥ 3,000/mm³
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Bilirubin ≤ 3 times ULN
• •ALT and AST ≤ 5 times ULN
• •Adequate surgical biliary drainage with no evidence of infection
• •Not pregnant or nursing
• •Negative pregnancy test for women of childbearing age and childbearing potential
• •Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended
• •Must provide written informed consent
• •No history of other malignant diseases within the past 5 years other than adequately treated nonmelanoma skin cancer or in situ carcinoma of the uterine cervix
• •No serious co-existing medical condition likely to interfere with protocol treatment, including a potential serious infection
• •No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
• •No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance
• •No other serious uncontrolled medical conditions
• •No unresolved biliary tree obstruction
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Completely recovered from prior surgery
• •No use of other investigational agents within 28 days prior to and during study treatment
• •No prior chemotherapy or radiotherapy for biliary tract cancer
• •No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent