SIGNIFICANT ONGOING CLINICAL TRIALS

Definitive, Late Phase Trials

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

http://clinicaltrials.gov/ct2/show/NCT00326898

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 III renal adjuvant study in over a decade. It involves the cooperation of two competing pharmaceutical companies—Bayer and Pfizer—in the phase III 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 will include translational studies that may identify molecular profiles associated with response. This trial will collect and store kidney tissue removed at surgery. E2805 is accruing ahead of schedule with more than a third of the total accrual of 1,332 patients enrolled as of October 2007.