Celecoxib and Erlotinib in Treating Patients With Liver Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histological evidence of hepatocellular carcinoma (HCC)
• •* No evidence of residual or recurrent disease
• •Received 1 of the following therapies:
• •* Tumor resection between 4-8 weeks prior to study enrollment
• •* Transarterial chemo-embolization between the past 4-8 weeks
• •* Radiofrequency ablation and percutaneous ethanol injection (sequential or combinations thereof) between the past 2-8 weeks
• •Meets 1 of the following high-risk features for recurrence:
• •* History of resection of a single HCC \> 5 cm
• •* History of multifocal HCC (includes microsatellite disease found at time of resection)
• •* History of vascular invasion (macro or micro)
• •* History of poorly differentiated HCC
• •* Underlying cirrhosis
• •No Child-Pugh class C cirrhosis
• •PATIENT CHARACTERISTICS:
• •Absolute neutrophil count \> 1,500/mm\^3
• •Platelet count ≥ 75,000/mm\^3
• •Hemoglobin ≥ 9.0 g/dL
• •Creatinine ≤ 2.0 mg/dL
• •Bilirubin ≤ 2.0 mg/dL
• •AST/ALT ≤ 3 times upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 3 times ULN
• •INR ≤ 1.5 times ULN
• •Albumin ≥ 2.5 g/dL
• •ECOG performance status 0-2
• •Life expectancy ≥ 2 years
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
• •No other malignancy within the past 5 years except nonmelanoma skin cancer
• •Patients must agree not to wear contact lenses
• •No history of ulcer disease or gastrointestinal bleeding
• •No myocardial infarction within the past 18 months
• •No cerebral vascular event within the past 18 months
• •No history of aspirin or NSAID-induced asthma
• •No history of Gilbert's syndrome
• •No history of hypersensitivity reaction or allergy to sulfa drugs, aspirin, or other NSAIDs
• •No liver transplantation candidates for phase I portion of the study
• •No New York Heart Association class III or IV cardiac disease
• •No interstitial lung disease
• •No gastrointestinal disease prohibiting oral medication or requiring IV alimentation
• •No active peptic ulcer disease
• •No unstable angina pectoris
• •No ongoing, active, or untreated infection
• •No hypersensitivity to celecoxib
• •No rising alpha-fetal protein (AFP) not attributable to hepatitis B or C virus
• •No psychiatric illness or social situation that would preclude study compliance
• •PRIOR CONCURRENT THERAPY:
• •No prior liver transplantation
• •No prior chemotherapy or biologic therapy in the adjuvant setting
• •No prior chest or mantle radiotherapy
• •No concurrent aspirin or other nonsteroidal anti-inflammatory drug (NSAID)
• •No concurrent interferon
• •No concurrent oral steroids
• •No concurrent anticoagulant therapy
• •No concurrent CYP3A4 inducers or inhibitors
• •No concurrent commercial or other investigational anticancer agents or therapies
• •No concurrent selective cyclooxygenase-2 inhibitors
• •No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy