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Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery - NCT00335829-21231(Clinical Trial 145160)



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City:  Baltimore
State:  
MD
Zip Code: 21231
Conditions: Liver Cancer
Purpose: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together with chemoembolization may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.
Study summary: OBJECTIVES: Primary - Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy. Secondary - Characterize the safety and toxicity of this regimen in these patients. - Determine the response rate in patients treated with this regimen. OUTLINE: Patients receive bevacizumab once in weeks 1, 3, and 5. Beginning in week 3, patients also receive transarterial chemoembolization (TACE) therapy. Treatment repeats approximately every 8 weeks for up to 3 courses. Patients achieving < 100% necrosis by MRI after the first course receive 2 additional courses of bevacizumab and TACE. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed* hepatocellular carcinoma - Unresectable disease - Child's class A or B with liver-predominant and asymptomatic extrahepatic disease NOTE: *A highly suspicious liver mass on CT scan or MRI in the presence of alpha fetoprotein > 200 mg/dL may be used as alternative diagnostic criterion PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Absolute neutrophil count > 1,500/mm³ - Platelet count > 50,000/mm³ - AST and ALT < 5.0 times upper limit of normal (ULN) - Bilirubin ≤ 5.0 mg/dL - Creatinine normal OR creatinine clearance > 50 mL/min - No significant traumatic injury within the past 28 days - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months - No serious, nonhealing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: - No major surgery or open biopsy within the past 28 days - No minor surgery (e.g., fine-needle aspirations or core biopsies) within the past 7 days - No chemotherapy within the past 4 weeks - No radiotherapy within the past 21 days - No concurrent major surgery - No other concurrent chemotherapy - No other concurrent investigational drugs
Study is available at: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, MD 21231
United States

Primary Contact:
Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce
Email: jhcccro@jhmi.edu
Phone: 410-955-8804
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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