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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Genentech Novartis |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00323739 |
This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination in patients previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: bevacizumab Drug: RAD001 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Bevacizumab(Avastin) and RAD001(Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bevacizumab 10mg/kg, IV infusion, every 2 weeks RAD001 10 mg by mouth daily
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Drug: bevacizumab
Bevacizumab 10mg/kg, IV infusion, every 2 weeks
Drug: RAD001
RAD001 10 mg by mouth daily
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All eligible patients will receive:
All patients will be evaluated for response after completing two courses (8 weeks) of treatment. Patients with objective tumor response or stable disease will continue treatment with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease progression occurs.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
Florida Hospital Cancer Institute | |
Orlando, Florida, United States, 32804 | |
Integrated Community Oncology Network | |
Jacksonville, Florida, United States, 32256 | |
Gainsville Hematology Oncology Associates | |
Gainesville, Florida, United States, 32605 | |
United States, Georgia | |
Wellstar Cancer Research | |
Marietta, Georgia, United States, 30060 | |
United States, Kentucky | |
Consultants in Blood Disorders and Cancer | |
Louisville, Kentucky, United States, 40207 | |
United States, Louisiana | |
Baton Rouge General Medical Center | |
Baton Rouge, Louisiana, United States, 70806 | |
United States, Michigan | |
Grand Rapids Clinical Oncology Program | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Nebraska | |
Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 | |
United States, Ohio | |
Oncology Hematology Care | |
Cincinnati, Ohio, United States, 45242 | |
United States, Tennessee | |
Chattanooga Oncology Hematology Associates | |
Chattanooga, Tennessee, United States, 37404 | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 |
Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
Responsible Party: | SCRI Oncology Research Consortium ( John D. Hainsworth, M.D. ) |
Study ID Numbers: | SCRI GU 32, AVF3673s |
Study First Received: | May 5, 2006 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00323739 |
Health Authority: | United States: Institutional Review Board |
kidney cancer bevacizumab |
Everolimus Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |