Final phase II safety and efficacy results of study MC0452: Phase I/II trial of CCI 779 and bevacizumab in advanced renal cell carcinoma.

Abstract

4548 Background: Combined mTOR and VEGF blockade is a potentially promising and rational strategy for the treatment of advanced RCC. We previously reported the phase I safety and initial efficacy results of temsirolimus (T) +bevacizumab (B) in RTKI naive stage IV RCC patients (pts) (J Clin Oncol 2007, 25(18S Suppl):5034). We now report the final results of the phase II study of T+B in RCC patients (pts) previously treated with VEGFR TKI. Methods: Design: Open label, phase I/II study of T+B in advanced RCC pts. Pts with measurable stage IV RCC with a component of clear/conventional cell type, performance status 0-2 and good organ function were eligible. Up to two prior treatment regimens were allowed (at least one prior RTKI). Phase II dose was T=25 mg IV weekly and B= 10 mg/kg every 2 weeks repeated in 4 week cycles. The primary objective (phase II portion): to assess the proportion of patients who were progression-free 6 months after study entry. Secondary objectives: assessment of response rates and tox...