Clinical trial NCT00216437 (phase 1, status: terminated)
Conditions: cancer of liver
ICD codes: D13.4, Z85.05, C22.8, C78.7, D37.6, C22.9
Drugs: capecitabine (xeloda)
SMILES: [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]
Reason stopped: 
    lack of accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent prior to study-specific screening procedures, with
             the understanding that the patient has the right to withdraw from the study at any
             time, without prejudice.

          -  Age >18 years

          -  Ambulatory outpatients (if applicable), with Karnofsky performance status of >60

          -  Histologically or cytologically confirmed unresectable hepatocellular carcinoma, liver
             mets with no evidence of extrahepatic disease, or cholangiocarcinoma. (see exclusion
             criteria 10)

          -  At least one measurable lesion according to the RECIST criteria which has not been
             irradiated (i.e. newly arising lesions in previously irradiated areas are accepted).
             Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum
             indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional
             techniques.

          -  Protocol Specific Laboratory Values as described below in section 6.9 number15.

          -  Has a negative serum pregnancy test within 7 days prior to start of therapy (female
             patients of childbearing potential).

          -  Have concomitant medications been reviewed with patient to address contraindicated
             medications described in protocol section 6.2.8 and have precautions been taken as
             recommended for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine,
             Anticoagulants, Phenytoin, and Laxatives.

        Exclusion Criteria:

          -  Pregnant or lactating woman. Woman of childbearing potential with either a positive or
             no pregnancy test at baseline. Woman or men of childbearing potential not using a
             reliable and appropriate contraceptive method. (Postmenopausal woman must have been
             amenorrheic for at least 12 months to be considered of non-childbearing potential).
             Patients will agree to continue contraception for 30 days from the date of the last
             study drug administration

          -  Life expectancy < 3 months.

          -  Serious, uncontrolled, concurrent infection(s).

          -  Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed
             at least 12 months earlier).

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to
             5-fluorouracil or known DPD deficiency.

          -  Completion of previous chemotherapy regimen < four weeks prior to the start of study
             treatment, or with related toxicities unresolved prior to the start of study
             treatment.

          -  Treatment for other carcinomas within the last five years, except cured non-melanoma
             skin and treated in-situ cervical cancer.

          -  Participation in any investigational drug study within 4 weeks preceding the start of
             study treatment.

          -  Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
             coronary artery disease and cardiac arrhythmias not well controlled with medication)
             or myocardial infarction within the last 12 months.

          -  Evidence of extrahepatic disease or history of uncontrolled seizures, central nervous
             system disorders or psychiatric disability judged by the investigator to be clinically
             significant, precluding informed consent, or interfering with compliance of oral drug
             intake

          -  Other serious uncontrolled medical conditions that the investigator feels might
             compromise study participation.

          -  Major surgery within 4 weeks of the start of study treatment, without complete
             recovery.

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome.

          -  Known, existing uncontrolled coagulopathy

          -  Any of the following laboratory values:

               -  Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x
                  109/L)

               -  Impaired renal function (estimated creatinine clearance <50ml/min as calculated
                  with Cockroft-Gault equation.

               -  Serum bilirubin > 2.0 x upper normal limit.

               -  AST, ALT (SGOT/SGPT) > 2.5 x upper normal limit (or > 5 x upper normal limit in
                  the case of liver metastases).

               -  Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in
                  the case of liver metastases).

          -  Unwillingness to give written informed consent or provide HIPAA privacy authorization.

          -  Unwillingness to participate or inability to comply with the protocol for the duration
             of the study.

          -  Patient taking a contraindicated medication(s) described in section 6.2.8 (see
             inclusion criteria #8 for list of agents) and no appropriate substitute agent is
             available, or patient unable or refuses to take substitute agent.