A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain
I. Determine the partial and minor response rate in patients with renal cell carcinoma (RCC)
metastatic to the brain treated with sorafenib.
I. Determine the toxicity of sorafenib in patients with RCC metastatic to the brain.
II. Determine whether the effect of sorafenib on RCC metastatic to the brain is similar to
its effect on non-brain metastatic sites.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate by RECIST radiologic measurements every 8 weeks
Walter M. Stadler, MD, FACP
University of Chicago
United States: Food and Drug Administration
|Cardinal Bernardin Cancer Center at Loyola University Medical Center||Maywood, Illinois 60153-5500|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Evanston Northwestern Health Care - Evanston Hospital||Evanston, Illinois 60201|
|David C. Pratt Cancer Center at St. John's Mercy||St. Louis, Missouri 63141|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Ingalls Cancer Care Center at Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Oncology Hematology Associates of Central Illinois, PC - Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology||Fort Wayne, Indiana 46815|
|Oncology Care Associates, PLLC||Saint Joseph, Michigan 49085|