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Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
medroxyprogesterone
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometrial Cancer focused on measuring endometrial cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Cancer Center
  • Community Hospital of Los Gatos
  • Chao Family Comprehensive Cancer Center
  • Walter Reed Army Medical Center
  • University of Chicago Cancer Research Center
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center
  • Albert B. Chandler Medical Center, University of Kentucky
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • University of Mississippi Medical Center
  • Keesler Medical Center - Keesler AFB
  • Ellis Fischel Cancer Center - Columbia
  • Washington University School of Medicine
  • Cooper Hospital/University Medical Center
  • State University of New York Health Sciences Center - Stony Brook
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Barrett Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • University of Oklahoma College of Medicine
  • Abington Memorial Hospital
  • Milton S. Hershey Medical Center
  • Medical University of South Carolina
  • Brookview Research, Inc.
  • University of Texas Medical Branch
  • Fletcher Allen Health Care - Medical Center Campus
  • Cancer Center at the University of Virginia
  • Norwegian Radium Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 7, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003179
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Terminated
Study Start Date
November 1998 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
medroxyprogesterone

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Curtin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
George L. Mutter, MD
Organizational Affiliation
Dana-Farber/Brigham and Women's Cancer Center
First Name & Middle Initial & Last Name & Degree
Francisco A. R. Garcia, MD, MPH
Organizational Affiliation
University of Arizona
First Name & Middle Initial & Last Name & Degree
Richard Zaino, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Community Hospital of Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Keesler Medical Center - Keesler AFB
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper Hospital/University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1489
Country
United States
Facility Name
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8091
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1065
Country
United States
Facility Name
Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0526
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3788
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-2233
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0587
Country
United States
Facility Name
Fletcher Allen Health Care - Medical Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22155796
Citation
Bartels PH, Garcia FA, Trimble CL, Kauderer J, Curtin J, Lim PC, Hess LM, Silverberg S, Zaino RJ, Yozwiak M, Bartels HG, Alberts DS. Karyometry in atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Apr;125(1):129-35. doi: 10.1016/j.ygyno.2011.12.422. Epub 2011 Dec 9.
Results Reference
result
PubMed Identifier
16400639
Citation
Trimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ 2nd, Alberts D, Curtin J. Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer. 2006 Feb 15;106(4):812-9. doi: 10.1002/cncr.21650.
Results Reference
result

Learn more about this trial

Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

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