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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00881751 |
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. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab, erlotinib, and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab together with erlotinib is more effective than giving sorafenib in treating patients with liver cancer.
PURPOSE: This randomized phase II trial is studying how well giving bevacizumab together with erlotinib works compared with sorafenib as first-line therapy in treating patients with advanced liver cancer.
Condition | Intervention | Phase |
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Liver Cancer |
Biological: bevacizumab Drug: erlotinib hydrochloride Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Open-Label Multi-Institution Phase II Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC) |
Estimated Enrollment: | 120 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.
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Biological: bevacizumab
Given IV
Drug: erlotinib hydrochloride
Given orally
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Arm II: Active Comparator
Patients receive oral sorafenib tosylate twice daily on days 1-28.
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Drug: sorafenib tosylate
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 30 days and then every 3 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed advanced hepatocellular carcinoma (HCC)
Measurable disease as per RECIST criteria, defined as ≥ 1 previously unirradiated, bidimensionally measurable lesion ≥ 20 mm by CT scan or MRI (triphasic spiral CT scan or MRI employing a "liver protocol" image capture technique required)
PATIENT CHARACTERISTICS:
PT ≤ 1.8 times ULN
No uncontrolled or significant cardiovascular disease, including any of the following:
No grade 3 bleeding esophageal or gastric varices within the past 2 months
PRIOR CONCURRENT THERAPY:
United States, South Carolina | |
Hollings Cancer Center at Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 |
Principal Investigator: | Melanie B. Thomas, MD | Medical University of South Carolina |
Responsible Party: | Hollings Cancer Center at Medical University of South Carolina ( Melanie B. Thomas ) |
Study ID Numbers: | CDR0000640337, MUSC-101282, GENENTECH-AVF4481s |
Study First Received: | April 14, 2009 |
Last Updated: | June 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00881751 History of Changes |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer |
Erlotinib Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Bevacizumab Protein Kinase Inhibitors Angiogenesis Inhibitors Recurrence |
Carcinoma Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Liver Diseases Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Protein Kinase Inhibitors Liver Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Erlotinib |
Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |