Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

Condition(s) targeted: Endometrial Cancer

Intervention: danazol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gynecologic Oncology Group

Official(s) and/or principal investigator(s):
Allan Covens, MD, Study Chair, Affiliation: Edmond Odette Cancer Centre at Sunnybrook

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.

Official title: Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer

Study design: Treatment

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

University of Alabama Comprehensive Cancer Center, Birmingham, Alabama 35294, United States

CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States

Chao Family Comprehensive Cancer Center, Orange, California 92868, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California 90033-0800, United States

Women's Cancer Center, Palo Alto, California 94304, United States

University of Colorado Cancer Center, Denver, Colorado 80262, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington, District of Columbia 20007, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States

Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612-7323, United States

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5265, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States

Johns Hopkins Oncology Center, Baltimore, Maryland 21287, United States

Medicine Branch, Bethesda, Maryland 20892, United States

Radiation Oncology Branch, Bethesda, Maryland 20892, United States

Tufts University School of Medicine, Boston, Massachusetts 02111, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Washington University School of Medicine, Saint Louis, Missouri 63110, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Cooper Hospital/University Medical Center, Camden, New Jersey 08103, United States

Cancer Center of Albany Medical Center, Albany, New York 12208, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

North Shore University Hospital, Manhasset, New York 11030, United States

State University of New York Health Science Center at Brooklyn, Brooklyn, New York 11203, United States

State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York 11790-9832, United States

University of Rochester Cancer Center, Rochester, New York 14642, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1082, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio 45219, United States

Cleveland Clinic Cancer Center, Cleveland, Ohio 44195, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

CCOP - Sooner State, Tulsa, Oklahoma 74136, United States

University of Oklahoma College of Medicine, Oklahoma City, Oklahoma 73190, United States

NCIC-Clinical Trials Group, Kingston, Ontario K7L 3N6, Canada

Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario M4N 3M5, Canada

CCOP - Columbia River Program, Portland, Oregon 97213, United States

Abington Memorial Hospital, Abington, Pennsylvania 19001, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107, United States

Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

Brookview Research, Inc., Nashville, Tennessee 37203, United States

CCOP - Baptist Cancer Institute, Memphis, Tennessee 38117, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Simmons Cancer Center - Dallas, Dallas, Texas 75235-9154, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States

Cancer Center, University of Virginia HSC, Charlottesville, Virginia 22908, United States

Tacoma General Hospital, Tacoma, Washington 98405, United States

University of Washington Medical Center, Seattle, Washington 98195-6043, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 1999
Last updated: May 23, 2008