S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery

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OBJECTIVES: Primary to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Secondary To compare the overall survival of patients treated with everolimus vs placebo. To compare qu...

OBJECTIVES: Primary to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Secondary To compare the overall survival of patients treated with everolimus vs placebo. To compare qualitative and quantitative toxicity between the two study arms. To bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value. To bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus. OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Archived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.

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