PRIMARY OBJECTIVES: l. To compare the overall survival of patients receiving bevacizumab plus everolimus and everolimus alone among patients with advanced renal cell carcinoma progressing after first line VEGFR-TKI treatment. SECONDARY OBJECTIVES: I. To compare the progression-free survival and proportion who experience an objective response (defined as cCR + PR) in patients with advanced renal cell carcinoma receiving bevacizumab plus everolimus and everolimus alone. II. To compare grade 3 or higher toxicity in patients receiving each treatment regimen. OUTLINE: This is a multicenter study. Patients are stratified according to number of risk factors (i.e., Karnofsky performance status < 80%, corrected serum calcium >= 10 mg/dL, and hemoglobin =< 13 g/dL for male patients or =< 11.5 g/dL for female patients) present (0 vs 1 vs 2-3) and total duration of prior VEGFR tyrosine kinase inhibitor therapy (< 12 weeks vs >= 12 weeks). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive everolimus orally (PO) once daily on days 1-28. ARM II: Patients receive everolimus PO once daily on days 1-28 and bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood, urine, and tumor tissue samples may be collected periodically for pharmacogenomic and correlative studies. After completion of study treatment, patients are followed up every 8 weeks until disease progression and then every 6 months for up to 5.5 years.
Last updated: 02/25/2013