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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00378703 |
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. Bevacizumab and sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving different combinations of bevacizumab, sorfenib, and temsirolimus may be more effective than bevacizumab alone in treating metastatic kidney cancer.
PURPOSE: This randomized phase II trial is studying different combinations of bevacizumab, temsirolimus, and sorafenib to see how well they work compared with bevacizumab alone in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: bevacizumab Drug: sorafenib tosylate Drug: temsirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | The BeST Trial: A Randomized Phase II Study of VEGF, RAF Kinase, and mTOR Combination Targeted Therapy (CTT) With Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma [BeST] |
Estimated Enrollment: | 360 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Active Comparator
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15.
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Drug: bevacizumab
Given IV
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Arm B: Experimental
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in arm A.
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Drug: bevacizumab
Given IV
Drug: temsirolimus
Given IV
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Arm C: Experimental
Patients receive bevacizumab as in arm A and oral sorafenib tosylate twice daily on days 1-28.
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Drug: bevacizumab
Given IV
Drug: sorafenib tosylate
Given orally
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Arm D: Experimental
Patients receive temsirolimus as in arm B and sorafenib tosylate as in arm C.
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Drug: sorafenib tosylate
Given orally
Drug: temsirolimus
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior cytokine or vaccine therapy (no vs yes) and Motzer risk category (low vs intermediate vs high). Patients are randomized to 1 of 4 treatment arms.
In all arms treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed clear cell renal cell carcinoma
Sufficient pathology material available for diagnostic review
Prior nephrectomy required, with the following exceptions:
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
Uncontrolled hypertension
No significant proteinuria
PRIOR CONCURRENT THERAPY:
No concurrent cytochrome P450 enzyme-inducing drugs including any of the following:
Study Chair: | Keith T. Flaherty, MD | University of Pennsylvania |
Investigator: | David F. McDermott, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000499788, ECOG-E2804 |
Study First Received: | September 19, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00378703 |
Health Authority: | Unspecified |
recurrent renal cell cancer clear cell renal cell carcinoma stage IV renal cell cancer |
Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |