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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00684996 |
RATIONALE: Monoclonal antibodies, such as bevacizumab and MEDI-522, 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 and MEDI-522 may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without MEDI-522 in treating kidney cancer.
PURPOSE: This phase I/randomized phase II trial is studying the side effects and best dose of bevacizumab and to see how well it works when given together with or without MEDI-522 in treating patients with unresectable or metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: bevacizumab Drug: etaracizumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A PHASE I AND A RANDOMIZED PHASE II STUDY OF MAXIMAL ANGIOGENIC BLOCKADE IN ADVANCED RENAL CARCINOMA: BEVACIZUMAB (NSC-704865) WITH OR WITHOUT MEDI-522 (NSC-719850) |
Estimated Enrollment: | 142 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase II Arm I: Active Comparator
Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
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Drug: bevacizumab
Given IV
Drug: etaracizumab
Given IV
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Phase II Arm II: Active Comparator
Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
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Drug: etaracizumab
Given IV
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OBJECTIVES:
OUTLINE: This is a multicenter, phase I, dose-escalation study of bevacizumab followed by a randomized phase II study.
Phase II: Patients are stratified according to the number of prior treatment regimens for renal cell carcinoma (1 vs 2) and whether there is a clear cell component (yes vs no). Patients are randomized to 1 of 2 treatment arms:
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for up to 3 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma
Measurable disease
More than 6 months since prior and no concurrent treated or untreated brain metastases
PATIENT CHARACTERISTICS:
No unstable symptomatic arrhythmia requiring medication
None of the following cardiovascular conditions within the past 6 months:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior radiotherapy and recovered
Concurrent full-dose anticoagulation with warfarin allowed provided INR is between 2-3
United States, California | |
Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Recruiting |
Marysville, California, United States, 95901 | |
Contact: Primo N. Lara, Jr. 908-541-4500 | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109-0942 | |
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
United States, North Carolina | |
Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
Charlotte, North Carolina, United States, 28233-3549 | |
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
Wayne Memorial Hospital, Incorporated | Recruiting |
Goldsboro, North Carolina, United States, 27534 | |
Contact: James N. Atkins, MD 919-580-0000 | |
United States, Virginia | |
Danville Regional Medical Center | Recruiting |
Danville, Virginia, United States, 24541 | |
Contact: Clinical Trials Office - Danville Regional Medical Center 434-799-3753 |
Study Chair: | Christopher W. Ryan, MD | Oregon Health and Science University Cancer Institute |
Investigator: | Theresa M. Koppie, MD | University of California, Davis |
Investigator: | Philip C. Mack, PhD | University of California, Davis |
Study ID Numbers: | CDR0000596555, SWOG-S0717 |
Study First Received: | May 24, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00684996 |
Health Authority: | Unspecified |
stage IV renal cell cancer recurrent renal cell cancer stage III renal cell cancer |
Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
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 |