Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer
RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer.
PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer|
|Study Start Date:||August 1999|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the antitumor activity of danazol in patients with advanced or recurrent endometrial cancer. II. Determine the nature and toxicity of danazol in these patients.
OUTLINE: Patients receive oral danazol 4 times per day for at least 4 weeks. Patients with partial response, complete response, or stable disease continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study within 26 months.