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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335829 |
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.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: bevacizumab Procedure: chemotherapy Procedure: embolization therapy Procedure: intrahepatic infusion procedure |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* hepatocellular carcinoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Jeffrey F. Geschwind, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000483104, JHOC-J0598, JHOC-NA_00001249 |
Study First Received: | June 8, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00335829 |
Health Authority: | Unspecified |
localized unresectable adult primary liver cancer adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Bevacizumab Recurrence Carcinoma |
Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |