Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Cancer
Intervention: medroxyprogesterone (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Gynecologic Oncology Group Official(s) and/or principal investigator(s):
John P. Curtin, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
George L. Mutter, MD, Affiliation: Dana-Farber/Brigham and Women's Cancer Center
Francisco A. R. Garcia, MD, MPH, Affiliation: University of Arizona
Richard Zaino, MD, Affiliation: Milton S. Hershey Medical Center
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.
Clinical Details
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 design: Prevention, Randomized, Active Control
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Norwegian Radium Hospital, Oslo N-0310, Norway
Arizona Cancer Center, Tucson, Arizona 85724-5024, United States
Chao Family Comprehensive Cancer Center, Orange, California 92868, United States
Community Hospital of Los Gatos, Los Gatos, California 95032, United States
Walter Reed Army Medical Center, Washington, District of Columbia 20307-5001, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States
Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa 52242-1009, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States
University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States
Washington University School of Medicine, Saint Louis, Missouri 63110, United States
Cooper Hospital/University Medical Center, Camden, New Jersey 08103-1489, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York 11794-8091, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1065, United States
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States
Barrett Cancer Center, Cincinnati, Ohio 45267-0526, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma 73190, United States
Abington Memorial Hospital, Abington, Pennsylvania 19001-3788, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States
Medical University of South Carolina, Charleston, South Carolina 29425-2233, United States
Brookview Research, Inc., Nashville, Tennessee 37203, United States
University of Texas Medical Branch, Galveston, Texas 77555-0587, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont 05401, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia 22908, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 1998
Last updated: May 23, 2008
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