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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

🇺🇸

Birmingham, Alabama, United States

CCOP - Greater Phoenix

🇺🇸

Phoenix, Arizona, United States

USC/Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

Women's Cancer Center

🇺🇸

Palo Alto, California, United States

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University

🇺🇸

Washington, District of Columbia, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

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University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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