Clinical trial NCT00363584 (phase 3, status: completed)
Conditions: extrahepatic bile duct cancer, gallbladder cancer, liver cancer
ICD codes: C24.0, D13.5, C23, D37.6, D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility 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