Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer

Inclusion Criteria: Histologically confirmed hepatocellular carcinoma Confirmed by needle aspirate, biopsy, or prior surgical resection specimen Clinically confirmed hepatocellular carcinoma defined as follows: Cirrhosis or chronic hepatitis B or C virus infection, with 1 or more hypervascular liver masses more than 2 cm Alpha-fetoprotein (AFP) greater than 400 ng/mL OR greater than 3 times normal and doubling in value during the past 3 months Deemed unresectable Prior surgical resection allowed Recurrence after hepatic resection or other procedure allowed Tumor that extends into branches of the portal or hepatic veins allowed No tumor invading the main portal vein (portal trunk) or inferior vena cava No tumor occupying more than 50% of the liver volume Enlargement/involvement of regional lymph nodes allowed At least 1 unidimensionally measurable lesion at least 20 mm No poorly defined lesions No vague hypervascular patches Child-Pugh class A or compensated Child-Pugh class B liver dysfunction No Child-Pugh class C or uncompensated class B indicated by active encephalopathy, persistent ascites, or prothrombin time greater than 1.5 times normal Prior ascites allowed if manageable with diuretics alone No repeated paracentesis (more than 1 per month) No extrahepatic metastasis No documented brain metastases No history or clinical evidence of CNS disease (e.g., primary brain tumor, seizures uncontrolled with standard medical therapy, or history of stroke) Performance status - ECOG 0-2 Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin at least 8 g/dL Platelet count at least 75,000/mm^3 No prior serious bleeding event (unrelated to liver disease) No bleeding diathesis No coagulopathy Bilirubin no greater than 3 mg/dL Transaminases less than 5 times upper limit of normal (ULN) Albumin at least 2.5 mg/dL PTT less than 4 seconds above ULN INR less than 1.5 (for patients receiving warfarin) Creatinine less than 1.5 g/dL Urine protein less than 500 mg/24hrs* Exclusion criteria: No thromboembolic event within the past 12 months No clinically significant cardiovascular disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring parenteral antibiotics No serious non-healing wound/ulcer or bone fracture No variceal bleeding within the past 6 months No malignancy within the past 5 years except localized nonmelanoma skin cancer No ongoing psychiatric or social situation that would preclude study compliance No known hypersensitivity to Chinese hamster ovary cell products No known hypersensitivity to other recombinant human antibodies No more than 1 prior biologic therapy No concurrent interferon No concurrent interleukin-2 No more than 1 prior antineoplastic chemotherapy At least 4 weeks since prior invasive surgery, including open biopsy At least 2 weeks since prior needle biopsy (core or fine-needle aspirate) No concurrent hepatic transplant At least 4 weeks since prior anticancer therapy No concurrent platelet-stimulating factors (e.g., oprelvekin) No concurrent full-dose anticoagulants or thrombolytic agents (except as required to maintain patency of pre-existing, permanent indwelling IV catheters) No chronic daily antiplatelet drugs (e.g., aspirin doses of 325 mg/day or higher or non-steroidal anti-inflammatory drugs)