Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed hepatocellular carcinoma (HCC) OR serum alpha fetoprotein ≥ 400 ng/mL with radiological evidence suggestive of HCC
• •* Unresectable disease
• •Child-Pugh class A or selected Child-Pugh class B disease (Child-Pugh score ≤ 7 points)
• •* No Child-Pugh class C disease
• •No disease outside the liver or macroscopic invasion of the major vessels such as the portal vein
• •No known brain metastasis
• •* Patients with neurological symptoms must undergo CT scan or MRI of the brain
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-1
• •WBC ≥ 3,000/mm³ (for patients scheduled to receive carboplatin) or ≥ 2,000/mm³ (for patients scheduled to receive cisplatin)
• •Platelet count ≥ 100,000/mm³ (for patients scheduled to receive carboplatin) or ≥ 60,000/mm³ (for patients scheduled to receive cisplatin)
• •Serum creatinine ≤ 1.9 mg/dL (for patients scheduled to receive carboplatin) or ≤ 1.5 mg/dL (for patients scheduled to receive cisplatin)
• •Serum total bilirubin ≤ 3 mg/dL
• •AST and ALT \< 5 times upper limit of normal
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• •No cardiac disease, including any of the following:
• •* NYHA class III-IV congestive heart failure
• •* Unstable angina (anginal symptoms at rest)
• •* New onset of angina within the past 3 months
• •* Myocardial infarction within the past 6 months
• •* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• •No uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management
• •No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
• •No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
• •No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
• •No evidence or history of bleeding diathesis or coagulopathy
• •No evidence of encephalopathy
• •No condition that would impair the ability to swallow whole pills
• •No history of malabsorption problems
• •No significant traumatic injury within the past 4 weeks
• •No serious non-healing wound, ulcer, or bone fracture
• •No active clinically serious infection
• •No known HIV infection
• •No known or suspected allergy to sorafenib tosylate or any other study agent
• •PRIOR CONCURRENT THERAPY:
• •No prior cisplatin, carboplatin, or sorafenib tosylate
• •No prior systemic chemotherapy for HCC
• •No other prior systemic or locoregional therapy
• •More than 4 weeks since prior major surgery or open biopsy
• •No concurrent St. John's wort or rifampin