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Home > "S" Clinical Trials Conditions > Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer  Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
For Condition: Endometrial Cancer
Status: No longer recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. - Patients are randomized to 1 of 2 arms. - Arm I: Patients receive oral medroxyprogesterone acetate (Provera) once daily for 3 months. - 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnCurtin, Study Chair, Memorial Sloan-Kettering Cancer Center
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
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
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Arizona Cancer Center
Tucson, Arizona, 85724-5024
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-2233
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Additional Information:
Study ID Numbers: CDR0000065999; GOG-167
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003179
Other Endometrial Cancer Studies:
1. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
2. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
3. Medroxyprogesterone in Treating Women With Breast Cancer
4. CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
5. Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Related Studies:
Other Endometrial Cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
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