A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
I. Determine the objective response rate in patients with advanced or recurrent uterine
cancer treated with sorafenib.
II. Determine the toxic effects of this drug in these patients.
I. Determine progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to histology
(carcinoma vs carcinosarcoma).
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate (complete or partial), as measured by RECIST criteria
Up to 5 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|City of Hope Medical Center||Duarte, California 91010|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Southern California||Los Angeles, California 90033|