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| Sponsor: | Medical University of South Carolina |
|---|---|
| Information provided by: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00881751 |
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. 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 |
|---|---|---|
|
Liver Cancer |
Biological: bevacizumab Drug: erlotinib hydrochloride Drug: sorafenib tosylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.
|
Biological: bevacizumab
Given IV
Drug: erlotinib hydrochloride
Given orally
|
|
Active Comparator: Arm II
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
Drug: sorafenib tosylate
Given orally
|
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.
Eligibility| 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:
Contacts and Locations| Contact: Alan Brisendine, CCRP | (843) 792-9007 | brisend@musc.edu |
| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
| Los Angeles, California, United States, 90033-0804 | |
| Contact: Anthony B. El-Khoueiry, MD 323-865-3967 elkhouei@usc.edu | |
| California Pacific Medical Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Ari Baron, MD 415-923-4840 | |
| Contact: Brenda Eng 415-600-1775 | |
| United States, New York | |
| Columbia University/ New York Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Abby Siegel, MD 212-305-9781 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| 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 | |
| United States, Tennessee | |
| Tennessee Oncology, PLLC at Sarah Cannon Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Johanna Bendell, MD 615-329-7274 | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: Hanna Sanoff, MD 434-243-6531 | |
| Principal Investigator: | Melanie B. Thomas, MD | Medical University of South Carolina |
More Information
| Responsible Party: | Melanie B. Thomas, Hollings Cancer Center at Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00881751 History of Changes |
| Other Study ID Numbers: | CDR0000640337, MUSC-101282, GENENTECH-AVF4481s |
| Study First Received: | April 14, 2009 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer |
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Bevacizumab Sorafenib |
Erlotinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |