Study design and performance
death, Tumor, toxicity, Tumors, Cancer
TUMORS, DISEASE PROGRESSION, TUMOR, CANCER
This was a Phase II, single cohort, open‐label study conducted in compliance with Good Clinical Practice guidelines and the ethical principles of the Declaration of Helsinki. The two clinical study sites were the Dartmouth Cancer Center (Lebanon, NH) and University of Vermont Cancer Center (Burlington, VT) which recruited mRCC patients from these rural state populations. The study protocol and all amendments were reviewed by the Institutional Review Board at each center. The study was registered on Patients received sunitinib 50 mg PO daily for 4 weeks followed by a 2‐week rest. Following the rest period, patients received temsirolimus 25 mg IV weekly for 4 weeks followed by a 2‐week rest. This 12‐week dosing regimen of sunitinib followed by temsirolimus constituted one cycle of treatment (Figure Study design schema.The primary objective of this study was to determine the PFS in mRCC patients treated with this alternating targeted therapy, defined as the time from start of treatment to the first documentation of objective disease progression or to death from any cause, whichever occurred first. Secondary objectives were to determine the clinical response rate and to characterize the toxicity profile of the treatment regimen. Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors, RECIST 1.1 guidelines.