Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

Inclusion Criteria:

• Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection

  • No fibrolamellar HCC

• No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents

  • The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study

    • Surgery
    • Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection)

• At least 1 unidimensionally measurable lesion

  • At least 20 mm by conventional techniques
• Must have paraffin tissue block or unstained slides from biopsy or surgical specimen
• No known brain metastases
• No ascites that are refractory to conservative management (e.g., sodium restriction to 50 mEq/day dietary sodium and fluid restrictions and/or diuretics)
• Performance status - ECOG 0-2
• At least 16 weeks
• Granulocyte count at least 1,500/mm^3
• Platelet count at least 60,000/mm^3
• Hemoglobin at least 10 g/dL
• Bilirubin no greater than 1.8 mg/dL
• Albumin at least 2.5 g/dL
• AST/ALT no greater than 5 times upper limit of normal
• PT no greater than 1-3 seconds over normal
• No decompensated liver disease
• No jaundice
• No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius)
• No hyponatremia with sodium less than 125 mEq/L
• No portal hypertension with bleeding esophageal or gastric varices within the past 3 months
• Creatinine no greater than 2 mg/dL
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation
• No active peptic ulcer disease
• No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No other uncontrolled concurrent illness that would preclude study participation
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior surgical therapy affecting absorption
• More than 30 days since prior investigational agents
• No concurrent commercial or other investigational anticancer agents or therapies
• No concurrent combination antiretroviral therapy for HIV-positive patients