Clinical trial NCT00003179: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: endometrial cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 360
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Gatos
country: United States
facility: Community Hospital of Los Gatos
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center
state: Iowa
city: Lexington
country: United States
facility: Albert B. Chandler Medical Center, University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Marlene and Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Keesler AFB
country: United States
facility: Keesler Medical Center - Keesler AFB
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Camden
country: United States
facility: Cooper Hospital/University Medical Center
state: New Jersey
city: Stony Brook
country: United States
facility: State University of New York Health Sciences Center - Stony Brook
state: New York
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Barrett Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Brookview Research, Inc.
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care - Medical Center Campus
state: Vermont
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John P. Curtin, MD
role: STUDY_CHAIR
affiliation: Dana-Farber/Brigham and Women's Cancer Center
name: George L. Mutter, MD
affiliation: University of Arizona
name: Francisco A. R. Garcia, MD, MPH
affiliation: Milton S. Hershey Medical Center
name: Richard Zaino, MD
References:
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.
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.