A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)

This trial has two parts. The purpose of the first part of the trial is to determine the
doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in
combination. This part is currently closed to enrollment.

The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2
schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying
progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule.
The trial will also determine the number of patients whose cancer responds to the treatments,
whether life of patients can be extended, what the side effects are of the treatments, how
bothersome disease or treatment-related symptoms are to patients, and whether tests can be
found that will predict which patients may or may not respond to these treatments in the
future.