A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
Interventional
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
No
Gini Fleming
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2009-00068
NCT00238121
February 2005
Name | Location |
---|---|
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 |