Trial Details
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
NCT00003179
TERMINATED
DESCRIPTION
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.
CONDITIONS
Endometrial Cancer
ELIGIBILITY 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
