Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer

Completed · Phase 2

Conditions studied: Adult Primary Hepatocellular Carcinoma, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

In brief

This phase II trial is to see if bevacizumab works in treating patients who have unresectable nonmetastatic liver cancer that has not spread to the main portal vein. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

Key facts

Study ID

NCT00055692

Run by

National Cancer Institute (NCI)

People needed

46

Starts

2003-02-01

Expected to finish

2009-12-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Montefiore Medical Center - Moses Campus — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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