Uterine Carcinosarcoma Clinical Trial
Official title:
A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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