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Sponsors and Collaborators: |
Mount Sinai School of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055692 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Bevacizumab (RhuMAB-VEGF) In Hepatocellular Cancer For Patients With Unresectable Tumor (Without Invasion Of The Main Portal Vein Or Metastatic Disease) A Phase II Study |
Estimated Enrollment: | 46 |
Study Start Date: | February 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter, pilot study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-46 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
Clinically confirmed hepatocellular carcinoma defined as follows:
Deemed unresectable
At least 1 unidimensionally measurable lesion at least 20 mm
Child-Pugh class A or compensated Child-Pugh class B liver dysfunction
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No thromboembolic event within the past 12 months including the following:
No clinically significant cardiovascular disease including the following:
Pulmonary
Other
No variceal bleeding within the past 6 months
Prior esophageal varices allowed provided the following criteria are met:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 | |
NYU Cancer Institute at New York University Medical Center | |
New York, New York, United States, 10016 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Jonathan D. Schwartz, MD | Mount Sinai School of Medicine |
Study ID Numbers: | CDR0000270798, MTS-1002-532, NCI-5611 |
Study First Received: | March 6, 2003 |
Last Updated: | July 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00055692 |
Health Authority: | United States: Federal Government |
adult primary hepatocellular carcinoma recurrent adult primary liver cancer localized unresectable adult primary liver cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Neoplasm Metastasis Gastrointestinal Neoplasms Bevacizumab Recurrence Hepatocellular carcinoma Carcinoma |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |