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Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00003179
Collaborator
National Cancer Institute (NCI) (NIH)
360
Enrollment
31
Locations
11.6
Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia.

PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Primary Purpose:
Prevention
Official Title:
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
Study Start Date :
Nov 1, 1998
Actual Primary Completion Date :
Feb 1, 2006

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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724-5024
    2 Community Hospital of Los Gatos Los Gatos California United States 95032
    3 Chao Family Comprehensive Cancer Center Orange California United States 92868
    4 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5001
    5 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    6 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    7 Holden Comprehensive Cancer Center Iowa City Iowa United States 52242-1009
    8 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    9 Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    10 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    11 Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda Maryland United States 20892-1182
    12 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    13 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    14 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    15 Washington University School of Medicine Saint Louis Missouri United States 63110
    16 Cooper Hospital/University Medical Center Camden New Jersey United States 08103-1489
    17 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11794-8091
    18 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    19 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1065
    20 Barrett Cancer Center Cincinnati Ohio United States 45267-0526
    21 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    22 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    23 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    24 Abington Memorial Hospital Abington Pennsylvania United States 19001-3788
    25 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    26 Medical University of South Carolina Charleston South Carolina United States 29425-2233
    27 Brookview Research, Inc. Nashville Tennessee United States 37203
    28 University of Texas Medical Branch Galveston Texas United States 77555-0587
    29 Fletcher Allen Health Care - Medical Center Campus Burlington Vermont United States 05401
    30 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    31 Norwegian Radium Hospital Oslo Norway N-0310

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: John P. Curtin, MD, Memorial Sloan Kettering Cancer Center
    • : George L. Mutter, MD, Dana-Farber/Brigham and Women's Cancer Center
    • : Francisco A. R. Garcia, MD, MPH, University of Arizona
    • : Richard Zaino, MD, Milton S. Hershey Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003179
    Other Study ID Numbers:
    • CDR0000065999
    • GOG-0167
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 10, 2013
    Last Verified:
    Jul 1, 2006
    Keywords provided by , ,
    endometrial cancer
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Medroxyprogesterone Acetate
    Medroxyprogesterone

    Study Results

    No Results Posted as of Jun 10, 2013