Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma

Inclusion 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 CNS metastases (unless CNS metastases stable for > 3 months)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- Hemoglobin ≥ 9 g/dL

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 3 times ULN

- INR ≤ 1.5

- AST and 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 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