Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer
This study has been completed.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003946
First received: November 1, 1999
Last updated: January 7, 2012
Last verified: July 2004
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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 National Cancer Institute (NCI):
| Study Start Date: | August 1999 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003946
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| 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: | January 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV endometrial carcinoma recurrent endometrial carcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma 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 Neoplasms, Glandular and Epithelial 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 May 16, 2013