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A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera


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

Thank you

Trial Information

A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera


OBJECTIVES:

- Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients
diagnosed at initial biopsy to have complex atypical hyperplasia.

- Compare the histologic response rates in patients with atypical endometrial hyperplasia
treated with oral medroxyprogesterone acetate (Provera) vs intramuscular
medroxyprogesterone acetate suspension (Depo-Provera) .

OUTLINE: This is a randomized, two-part study.

- Part A: Patients undergo immediate hysterectomy.

- Part B: Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive oral medroxyprogesterone acetate (Provera) once daily for
3 months.

- Arm II: Patients receive medroxyprogesterone acetate suspension (Depo- Provera)
intramuscularly once monthly for 3 months (days 1, 31, and 62).

Patients undergo hysterectomy at the end of the third month.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A minimum of 360 patients for part A and 140 patients (70 per arm) for
part B will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed atypical endometrial hyperplasia with recommended treatment
with either:

- An immediate hysterectomy (Part A) OR

- A three-month delay prior to hysterectomy and a randomized choice of treatment
with oral medroxyprogesterone acetate (Provera) or medroxyprogesterone acetate
suspension (Depo-Provera) during the 3 months (Part B with arms I and II)

- Diagnosed by dilation and curettage, Novak curettage, Vabra aspirate or Pipelle
endometrial biopsy

- No recognized endometrial carcinoma

- Must not be considered inoperable

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Granulocyte count at least 1,500/mm^3

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 times normal

Cardiovascular

- No prior thrombophlebitis or thromboembolic phenomena

- No prior cerebrovascular disorders

Other:

- No prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ
of the uterine cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

John P. Curtin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065999

NCT ID:

NCT00003179

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Endometrial Hyperplasia
  • Adenoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Chao Family Comprehensive Cancer CenterOrange, California  92868
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
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
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Community Hospital of Los GatosLos Gatos, California  95032
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
University of Texas Medical BranchGalveston, Texas  77555-1329
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182