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Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer

7. juni 2013 opdateret af: Gynecologic Oncology Group

Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer

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.

Studieoversigt

Status

Afsluttet

Betingelser

Endometriecancer

Intervention / Behandling

Medicin: danazol

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gynecologic Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Allan Covens, MD, Toronto Sunnybrook Regional Cancer Centre

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Covens A, Brunetto VL, Markman M, Orr JW, Lentz SS, Benda J; Gynecologic Oncology Group. Phase II trial of danazol in advanced, recurrent, or persistent endometrial cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 Jun;89(3):470-4. doi: 10.1016/s0090-8258(03)00149-5.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 1999

Primær færdiggørelse (Faktiske)

1. juni 2003

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

24. juni 2004

Først opslået (Skøn)

25. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2013

Sidst verificeret

1. juli 2004

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000067139
GOG-0180

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .