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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012


Definitive, Late Phase Trials

A Randomized, Double-Blind Phase 3 Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma

There is currently no known effective adjuvant therapy for patients with localized kidney cancer; those who undergo resection remain at risk for relapse. This CTEP-sponsored trial represents the first randomized phase 3 renal adjuvant study in over a decade ( It involves the cooperation of two competing pharmaceutical companies — Bayer and Pfizer — in the phase 3 evaluation of recently approved agents with documented renal cell carcinoma activity.

Sorafenib and sunitinib, agents that inhibit the formation of tumor blood vessels among other things, were approved by FDA in late 2005 and early 2006, respectively. This intergroup trial, E2805, which is being led by the Eastern Cooperative Oncology Group (ECOG), opened in June 2006, within a few months of the drugs’ approvals by FDA for treatment of advanced renal cancer. Intermediate and high-risk renal cell carcinoma patients whose cancerous kidneys have been removed will be accrued to the study and randomized to three treatment arms (sorafenib, sunitinib, or placebo) for 54 weeks. The trial includes translational studies that may identify molecular profiles associated with response. This trial has also collected and stored kidney tissue removed at surgery. E2805 closed to accrual in September 2010 after completing its target enrollment of 1,923 patients.