Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003946
First received: November 1, 1999
Last updated: June 7, 2013
Last verified: July 2004
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: danazol
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: August 1999
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced or recurrent endometrial cancer that is not amenable to curative surgery or radiotherapy Measurable disease Tumor at least 1.0 cm by 1.0 cm per x-ray or physical exam OR Tumor at least 2.0 cm by 2.0 cm per CT scan, MRI, or ultrasound

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 No history of porphyria Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2 mg/dL Other: No concurrent or prior malignancy within past 5 years (except nonmelanoma skin cancer) or for which patient received chemotherapy Not pregnant or nursing Fertile patients must use effective contraception Must have tissue available for estrogen receptor/ progesterone receptor analysis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003946

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Women's Cancer Center
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612-7323
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
Medicine Branch
Bethesda, Maryland, United States, 20892
Radiation Oncology Branch
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-9832
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
CCOP - Sooner State
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States, 38117
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Canada, Ontario
NCIC-Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Allan Covens, MD Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003946     History of Changes
Other Study ID Numbers: CDR0000067139, GOG-0180
Study First Received: November 1, 1999
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage IV endometrial carcinoma
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014