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Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer

National Cancer Institute (NCI) · 2009
ClinicalTrials.gov · Datasets · License: Public Domain · 2009
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bevacizumabrenal-cell-carcinoma
Background: * Substantial preclinical antitumor synergy supports the exploration of the combination of antiangiogenic compounds (including sunitinib and bevacizumab) plus ixabepilone. In Vivo, synergistic activity between ixabepilone and bevacizumab has been demonstrated using the 151-B human renal carcinoma xenograft model and this synergy compares favorably with other antiangiogenic inhibitors (i.e. sunitinib). * Combination therapies of bevacizumab with chemotherapy demonstrated improved benefit compared with single-agent cytotoxics in multiple animal models and in humans. * Clinical activity of both compounds used as single agents has been demonstrated in a broad spectrum of solid tumors. Bevacizumab and ixabepilone, when used as a single agent, have demonstrated substantial activity in renal cell carcinoma. * Phase II studies with bevacizumab and ixabepilone suggest the absence of overlapping toxicities. * Development of a well-tolerated and active bevacizumab/ixabepilone combination has the potential to further improve the treatment of metastatic renal cell carcinoma (mRCC), and could represent a second-line option after sunitinib or sorafenib are no longer of benefit or are intolerable. Primary Objectives: * Determine the objective response rate of the combination of ixabepilone and bevacizumab in patients with relapsed or refractory mRCC. * Determine progression-free survival. * Characterize the toxicity of the combination of ixabepilone and bevacizumab in patients with mRCC. * Determine changes in biomarkers and evaluate correlation with clinical outcomes. Eligibility: * Pathologic confirmation of renal cell carcinoma (clear cell histology) by the Laboratory of Pathology, National Cancer Institute (NCI), or the Medical University of South Carolina. * Presence of metastatic renal carcinoma, after progression or intolerance to Vascular endothelial growth factor receptor (VEGFR) inhibitors (sunitinib and/or sorafenib). * Adequate organ and bone marrow fun
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