Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer

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