Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003179
First received: November 1, 1999
Last updated: June 7, 2013
Last verified: July 2006

November 1, 1999
June 7, 2013
November 1998
February 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003179 on ClinicalTrials.gov Archive Site
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Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Prevention
Endometrial Cancer
Drug: medroxyprogesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
360
Not Provided
February 2006   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Norway
 
NCT00003179
CDR0000065999, GOG-0167
Not Provided
Not Provided
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: John P. Curtin, MD Memorial Sloan-Kettering Cancer Center
Investigator: George L. Mutter, MD Dana-Farber/Brigham and Women's Cancer Center
Investigator: Francisco A. R. Garcia, MD, MPH University of Arizona
Investigator: Richard Zaino, MD Milton S. Hershey Medical Center
Gynecologic Oncology Group
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP