Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003179
• Other study ID #: CDR0000065999
• Secondary ID: GOG-0167
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 7, 2013
• Start date: November 1998

Study information

• Verified date: July 2006
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Drug:
• medroxyprogesterone

Locations

Country	Name	City	State
Norway	Norwegian Radium Hospital	Oslo
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Arizona Cancer Center	Tucson	Arizona
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Norway, 

References & Publications (2)

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. — View 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) — View Citation