Brief Title
Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
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
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.
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 Phase
Phase 2
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
medroxyprogesterone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
360
Start Date
November 1998
Primary Completion Date
February 2006
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
John P. Curtin, MD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT00003179
Organization ID
CDR0000065999
Secondary IDs
GOG-0167
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
John P. Curtin, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
July 2006