Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
About this trial
This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.