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Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

Phase 2
Completed
Conditions
Endometrial Cancer
Registration Number
NCT00003946
Lead Sponsor
Gynecologic Oncology Group
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (73)

University of Alabama Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

CCOP - Greater Phoenix

πŸ‡ΊπŸ‡Έ

Phoenix, Arizona, United States

USC/Norris Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Orange, California, United States

Women's Cancer Center

πŸ‡ΊπŸ‡Έ

Palo Alto, California, United States

University of Colorado Cancer Center

πŸ‡ΊπŸ‡Έ

Denver, Colorado, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University

πŸ‡ΊπŸ‡Έ

Washington, District of Columbia, United States

Walter Reed Army Medical Center

πŸ‡ΊπŸ‡Έ

Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

πŸ‡ΊπŸ‡Έ

Tampa, Florida, United States

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University of Alabama Comprehensive Cancer Center
πŸ‡ΊπŸ‡ΈBirmingham, Alabama, United States

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