Sorafenib and Everolimus in Advanced Clear Cell Renal Carcinoma: A Phase I/II Trial of the SCRI Oncology Research Consortium

Purpose: To evaluate the feasibility and efficacy of sorafenib and everolimus in renal cell carcinoma (RCC). Methods: Patients with advanced RCC and ≤1 previous targeted therapy were treated. Results: Maximum tolerated doses were sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly. Dose-limiting toxicity was hand–foot syndrome. The response rate was 13%; median PFS was 5.45 months (95% CI: 3.8–7.6). Skin toxicity, fatigue, hypertension, proteinuria, and mucositis (usually Grade 2) were common. Conclusions: Fifty percent doses of sorafenib and everolimus were required when these drugs were combined. No increase in efficacy was suggested; toxicity was modestly increased.