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Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Study of Danazol in Advanced or Recurrent Endometrial Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook

Authority:

United States: Federal Government

Study ID:

CDR0000067139

NCT ID:

NCT00003946

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
Women's Cancer CenterPalo Alto, California  94304
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Tufts University School of MedicineBoston, Massachusetts  02111
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Scott and White HospitalTemple, Texas  76508
North Shore University HospitalManhasset, New York  11030
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
CCOP - Sooner StateTulsa, Oklahoma  74136
Medicine BranchBethesda, Maryland  20892
Radiation Oncology BranchBethesda, Maryland  20892