Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction

Inclusion Criteria: Histologically or cytologically confirmed unresectable hepatocellular carcinoma (HCC) with or without extrahepatic metastasis No fibrolamellar HCC No more than 2 prior therapies for HCC, including systemic chemotherapy, chemoembolization, hepatic arterial infusion of chemotherapeutic agents, and other novel agents Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Moderate hepatic dysfunction with any of the following: Bilirubin 2-4 g/dL Albumin < 2.5 g/dL Ascites PT 2-4 seconds > upper limit of normal (ULN) AST/ALT 2.6-10 times > ULN 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 ≥ 1,500/mm^3 Platelet count ≥ 60,000/mm^3 Hemoglobin ≥ 10 g/dL No decompensated liver disease No jaundice No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius) No hyponatremia < 130 mEq/L No portal hypertension with bleeding esophageal or gastric varices within the past 3 months Creatinine ≤ 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 significant traumatic injury within the past 21 days 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 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered At least 4 weeks since prior radiotherapy and recovered No prior surgical therapy affecting absorption At least 21 days since prior major surgery At least 4 weeks since any other prior agents and recovered No prior epidermal growth factor-receptor targeting therapies No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients