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Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003946
Collaborator
National Cancer Institute (NCI) (NIH)
73
Locations

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer
Study Start Date :
Aug 1, 1999
Actual Primary Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033-0800
    4 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    5 Chao Family Comprehensive Cancer Center Orange California United States 92868
    6 Women's Cancer Center Palo Alto California United States 94304
    7 University of Colorado Cancer Center Denver Colorado United States 80262
    8 Vincent T. Lombardi Cancer Research Center, Georgetown University Washington District of Columbia United States 20007
    9 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    10 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    11 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    12 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    13 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
    14 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    15 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    16 CCOP - Central Illinois Decatur Illinois United States 62526
    17 CCOP - Evanston Evanston Illinois United States 60201
    18 Indiana University Cancer Center Indianapolis Indiana United States 46202-5265
    19 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    20 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    21 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    22 Johns Hopkins Oncology Center Baltimore Maryland United States 21287
    23 Medicine Branch Bethesda Maryland United States 20892
    24 Radiation Oncology Branch Bethesda Maryland United States 20892
    25 Tufts University School of Medicine Boston Massachusetts United States 02111
    26 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    27 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    28 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    29 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    30 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    31 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    32 CCOP - Kansas City Kansas City Missouri United States 64131
    33 Washington University School of Medicine Saint Louis Missouri United States 63110
    34 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    35 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68131
    36 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    37 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    38 Cancer Center of Albany Medical Center Albany New York United States 12208
    39 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    40 North Shore University Hospital Manhasset New York United States 11030
    41 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    42 University of Rochester Cancer Center Rochester New York United States 14642
    43 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-9832
    44 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    45 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    46 Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157-1082
    47 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    48 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    49 Cleveland Clinic Cancer Center Cleveland Ohio United States 44195
    50 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210
    51 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    52 CCOP - Sooner State Tulsa Oklahoma United States 74136
    53 CCOP - Columbia River Program Portland Oregon United States 97213
    54 Abington Memorial Hospital Abington Pennsylvania United States 19001
    55 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    56 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104
    57 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107
    58 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
    59 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    60 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
    61 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    62 CCOP - Greenville Greenville South Carolina United States 29615
    63 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    64 CCOP - Baptist Cancer Institute Memphis Tennessee United States 38117
    65 Brookview Research, Inc. Nashville Tennessee United States 37203
    66 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    67 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030
    68 CCOP - Scott and White Hospital Temple Texas United States 76508
    69 Cancer Center, University of Virginia HSC Charlottesville Virginia United States 22908
    70 University of Washington Medical Center Seattle Washington United States 98195-6043
    71 Tacoma General Hospital Tacoma Washington United States 98405
    72 NCIC-Clinical Trials Group Kingston Ontario Canada K7L 3N6
    73 Toronto Sunnybrook Regional Cancer Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Allan Covens, MD, Toronto Sunnybrook Regional Cancer Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003946
    Other Study ID Numbers:
    • CDR0000067139
    • GOG-0180
    First Posted:
    Jun 25, 2004
    Last Update Posted:
    Jun 10, 2013
    Last Verified:
    Jul 1, 2004
    Keywords provided by , ,
    stage IV endometrial carcinoma
    recurrent endometrial carcinoma
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Danazol

    Study Results

    No Results Posted as of Jun 10, 2013