Trial Information

Summary: 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)

You have been asked to take part in this research study because you have advanced renal cell (kidney) cancer that cannot be cured by removing your kidney.  The purpose of this study is to compare the effects of sunitinib malate given in two different doses and schedules. This will be done by comparing tumor response (whether tumor stays the same or shrinks), side effects, quality of life and overall length of life of subjects on each treatment.  Another purpose of this study is to draw a series of blood samples to see how the body processes this drug. Your participation in this study is expected to last for as long as your tumor is not growing and you are not having any unmanageable side effects up to a total of two years.  After your treatment on this study is over, your medical condition will be followed indefinitely for overall survival by review of your medical records or telephone calls.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: June 2, 2008 at 2:50:59 PM