Clinical trial NCT00658593 (phase 3, status: terminated)
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, gemcitabine hydrochloride
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    due to poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically proven adenocarcinoma of the biliary tree (intra- and
             extra-hepatic biliary ducts or gallbladder)

          -  Locally advanced, unresectable, or metastatic disease

               -  Patients with pathologically confirmed metastatic adenocarcinoma consistent with
                  biliary primary with clinical documentation of gallbladder or biliary tree
                  involvement and no evidence of another primary adenocarcinoma are eligible

          -  Must have evidence of disease but measurable disease is not required

               -  Chest x-ray and/or CT scan of the chest, CT scan or MRI of the abdomen, and other
                  radiological examination to document all disease sites have been done within 28
                  days prior to randomization

                    -  No repeat scan needed if a negative scan was performed within 35 days prior
                       to randomization

               -  Patients who have only one site of disease located inside a previous radiotherapy
                  field are eligible

                    -  Lesions within a previous radiotherapy field may be considered measurable if
                       documented ≥ 20% increase in size

                    -  If the lesion size increase has not been documented since the completion of
                       radiotherapy, and the lesion is still present (i.e. not CR), the lesion is
                       considered evaluable for this trial

          -  Patients with biliary duct obstruction are eligible provided all of the following
             criteria are met:

               -  Treatable, clinically relevant obstruction

               -  Obstruction has been relieved by internal endoscopic drainage/stenting,
                  palliative bypass surgery or percutaneous drainage prior to trial entry

          -  No ampullary carcinomas (i.e., arising from the ampulla of Vater)

          -  No central nervous system (CNS) metastases, including active, progressive brain or
             leptomeningeal metastases

               -  Patients with focal neurological symptoms must have had a CT scan to rule out CNS
                  metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Minimum life expectancy of 12 weeks

          -  Able (i.e. sufficiently fluent) and willing to complete the quality of life
             questionnaires in one of the validated languages

          -  Must be able to swallow and retain oral medication

          -  Hemoglobin > 90 g/L

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Total bilirubin < 3 times upper limit of normal(ULN)

          -  AST and/or ALT ≤ 5 times ULN

          -  Liver function tests stable and < 3 times ULN

          -  Serum creatinine < 160 µmol/L OR creatinine clearance > 60 mL/min

          -  Negative pregnancy test

          -  Fertile patients and their partners must agree to use adequate contraception prior to
             study entry, throughout the study, and for a period of 4 weeks after cessation of
             protocol therapy

          -  Patients must be accessible for treatment and follow-up

          -  No known dihydropyrimidine dehydrogenase deficiency

          -  No known hypersensitivity to gemcitabine or capecitabine

          -  No other active medical condition which would render the protocol treatment dangerous
             or impair the ability of the patient to receive protocol therapy, including, but not
             limited to, any of the following:

               -  Unstable angina

               -  Uncontrolled arrhythmia

               -  Heart failure

          -  No other condition (e.g. psychological, geographical, etc.) that does not permit
             compliance with the protocol

          -  No other malignancies except adequately treated nonmelanoma skin cancer, curatively
             treated in-situ cancer of the cervix, or other solid tumors curatively treated with no
             evidence of disease for > 5 years

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy for advanced or metastatic disease unless used in the following
             circumstances:

               -  Fluorouracil or gemcitabine given concurrently with radiotherapy as a
                  radiosensitizer, completed more than 3 months prior to randomization

               -  Fluorouracil given as adjuvant treatment following surgery, completed at least 1
                  year prior to randomization

          -  No major surgery within 4 weeks of randomization

          -  No prior treatment with another investigational agent within 2 weeks of randomization

          -  At least 4 weeks from randomization since completion of prior radiotherapy and
             recovered

               -  Patients may be randomized within the required 4 weeks if short course (< 5
                  fractions) of non-myelosuppressive radiotherapy was given

          -  Concurrent palliative radiation to a known site of bone metastasis allowed provided
             that the criteria for disease progression are otherwise not met

          -  No other concurrent anti-cancer therapy (cytotoxic, biological/immunotherapy or
             radiotherapy other than for known bone metastases as specified above)

          -  No other concurrent investigational drug therapy