Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma

16020 Background: Concurrent targeting of parallel signaling pathways may improve the efficacy of anticancer agents and abrogate resistance mechanisms. Temsirolimus, an mTOR inhibitor, significantly prolongs overall survival (OS) (P=.008) and progression-free survival (PFS) (P<.001) vs interferon alfa (IFN) in patients with previously untreated, advanced renal cell carcinoma (RCC) and poor-risk features (Hudes et al. N Engl J Med 2007;356:2271). Sunitinib, a multikinase inhibitor, significantly prolongs PFS vs IFN (P<.001) in patients with previously untreated RCC (Motzer et al. N Engl J Med 2007;356). This study was conducted to evaluate the safety and efficacy of temsirolimus in combination with sunitinib in patients with advanced RCC. Methods: The objective was to determine the maximum tolerated dose. Eligibility included advanced RCC and up to 2 prior systemic regimens. At the starting dose, temsirolimus 15 mg was administered by intravenous (IV) infusion once weekly, and sunitinib 25 mg was administe...