Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	Not specified	NCI	GOG-0167 NCT00003179

Objectives

1. Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients diagnosed at initial biopsy to have complex atypical hyperplasia.
2. Compare the histologic response rates in patients with atypical endometrial hyperplasia treated with oral medroxyprogesterone acetate (Provera) vs intramuscular medroxyprogesterone acetate suspension (Depo-Provera) .

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• Granulocyte count at least 1,500/mm³

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

Expected Enrollment

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

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.

Trimble CL, Kauderer J, Zaino R, et al.: Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer 106 (4): 812-9, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

John Curtin, MD, Protocol chair(Contact information may not be current)		Ph: 212-639-2493; 800-525-2225 Email: curtinj@mskcc.org
George Mutter, MD, Protocol co-chair		Ph: 617-732-6096; 800-638-6294
Francisco Garcia, MD, MPH, Protocol co-chair		Ph: 520-626-8539; 800-622-2673
Richard Zaino, MD, Protocol co-chair		Ph: 717-531-8246

Registry Information
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
Trial Start Date		1998-11-09
Registered in ClinicalTrials.gov		NCT00003179
Date Submitted to PDQ		1998-01-09
Information Last Verified		2006-07-20
NCI Grant/Contract Number		CA27469

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