Celecoxib and Erlotinib in Treating Patients With Liver Cancer
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer
Eligibility 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
Sites / Locations
- UCSF Comprehensive Cancer Center