NCT00003946

Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	danazol

Timeline

• Start date: 1999-08-01
• Primary completion: 2003-06-01
• First posted: 2004-06-25
• Last updated: 2013-06-10

Locations

73 sites across 2 countries: United States, Canada