Clinical trial NCT00483405 (phase 2, status: completed)
Conditions: liver cancer
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: capecitabine, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Meets 1 of the following criteria:

               -  Histologically confirmed hepatocellular carcinoma

               -  Alpha-fetoprotein (AFP) > 400 ng/mL with compatible mass by CT scan or MRI

          -  Metastatic disease OR not a candidate for surgical resection or immediate liver
             transplantation

          -  At least 1 site of measurable disease OR evaluable disease (AFP 2 times upper limit of
             normal (ULN))

          -  No evidence of central nervous system (CNS) metastases (unless CNS metastases stable
             for > 3 months)

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 3 times ULN

          -  International normalized ratio (INR) ≤ 1.5

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN

          -  Creatinine clearance > 50 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known hypersensitivity to capecitabine, cetuximab, or oxaliplatin or to other
             murine products

          -  No comorbid condition which is deemed by the investigator to have a life expectancy of
             < 6 months

          -  No New York Heart Association class III-IV coronary artery disease and/or heart
             failure

          -  No variceal bleeding within the past 60 days

          -  No other cancer within the past 5 years except cervical intraepithelial neoplasia,
             nonmelanoma skin cancer, ductal carcinoma in situ, chronic lymphocytic leukemia, or
             treated localized prostate cancer with a normal prostate specific antigen level

          -  No active drug or alcohol abuse

          -  No prior allergic reaction to a therapeutic antibody

          -  No serious, uncontrolled infection

          -  No history of uncontrolled seizures, CNS disorders, or psychiatric disability that, in
             the opinion of the investigator, would preclude study participation or compliance

          -  No other serious uncontrolled medical condition that, in the opinion of the
             investigator, would preclude study participation

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No malabsorption syndrome

          -  No known existing uncontrolled coagulopathy

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior participation in an investigational drug trial

          -  At least 4 weeks since prior major surgery and recovered

          -  At least 4 weeks since prior embolization, resection, or ablation

          -  No prior epidermal growth factor receptor (EGFR)-targeting therapy

          -  No prior systemic chemotherapy or hepatic artery infusion of chemotherapy

          -  No concurrent phenytoin

          -  No concurrent therapeutic warfarin

               -  Low-dose non-therapeutic warfarin to maintain patency of venous access devices
                  allowed