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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Genentech |
Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00455975 |
This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.
Condition | Intervention | Phase |
Renal Cancer Kidney Cancer |
Drug: Bevacizumab |
Phase II |
MedlinePlus related topics: | Cancer Kidney Cancer |
Drug Information available for: | Bevacizumab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma |
Estimated Enrollment: | 120 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.
One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.
If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Contact: John D. Hainsworth, M.D. | 615-329-7274 | jhainsworth@tnonc.com |
Contact: Trials Info | 615-329-7274 | trialsinfo@scresearch.net |
United States, Georgia | |||||
Northeast Georgia Medical Center | Recruiting | ||||
Gainesville, Georgia, United States, 30501 | |||||
United States, Kentucky | |||||
Consultants in Blood Disorders and Cancer | Recruiting | ||||
Louisville, Kentucky, United States, 40207 | |||||
Contact: Judy Sisk 502-897-1166 ext 129 jsisk@cbcdocs.com | |||||
United States, Nebraska | |||||
Methodist Cancer Center | Recruiting | ||||
Omaha, Nebraska, United States, 68114 | |||||
United States, North Carolina | |||||
Cancer Care of Western North Carolina | Recruiting | ||||
Asheville, North Carolina, United States, 28801 | |||||
United States, Ohio | |||||
Aultman Hospital | Recruiting | ||||
Canton, Ohio, United States, 44710 | |||||
Oncology Hematology Care | Recruiting | ||||
Cincinnati, Ohio, United States, 45242 | |||||
Contact: Research Program Coordinator 513-891-4800 contact@ohcmail.com | |||||
United States, South Carolina | |||||
Spartanburg Regional Medical Center | Recruiting | ||||
Spartanburg, South Carolina, United States, 29303 | |||||
Contact: Nancy Sprouse 864-560-6016 nsprouse@srhs.com | |||||
United States, Tennessee | |||||
Chattanooga Oncology Hematology Associates | Recruiting | ||||
Chattanooga, Tennessee, United States, 37404 | |||||
Contact: Research Coordiantor 423-698-1844 research@cohaonline.com | |||||
Tennessee Oncology, PLLC | Recruiting | ||||
Nashville, Tennessee, United States, 37023 | |||||
Associates in Hematology Oncology | Recruiting | ||||
Chattanooga, Tennessee, United States, 37404 | |||||
Family Cancer Center | Recruiting | ||||
Collierville, Tennessee, United States, 38017 | |||||
United States, Virginia | |||||
Peninsula Cancer Institute | Recruiting | ||||
Newport News, Virginia, United States, 23601 |
Sarah Cannon Research Institute |
SCRI Oncology Research Consortium |
Genentech |
Study Chair: | John D. Hainsworth, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( John D. Hainsworth, M.D. ) |
Study ID Numbers: | SCRI GU 43, AVF 3913s |
First Received: | April 3, 2007 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00455975 |
Health Authority: | United States: Food and Drug Administration |
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