RATIONALE: Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.

PURPOSE: Phase II trial to study the effectiveness of medroxyprogesterone in treating patients who have endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix).

Condition	Treatment or Intervention	Phase
Endometrial Cancer	Drug: medroxyprogesterone  Procedure: conventional surgery  Procedure: endocrine therapy  Procedure: gene expression profiling  Procedure: genetic analysis  Procedure: hormone therapy  Procedure: neoadjuvant therapy  Procedure: progestin therapy  Procedure: surgery	Phase II

Further Study Details: 

OBJECTIVES:

• Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.
• Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.
• Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response, steroid receptor status, immunohistochemical measures of growth and apoptosis, and gene expression profiles in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.

A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus
• All histologic grades and stages eligible
• Diagnosis by endometrial curettage or biopsy within the past 8 weeks
• Must have the initial tissue block or 16 unstained sections of 5 micron thickness available

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• GOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No history of thrombophlebitis or thromboembolic disorders

Other

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No prior hormonal therapy within 3 months before diagnosis
• No concurrent aminoglutethimide

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• No prior cancer treatment that would preclude study therapy
• No concurrent bosentan
• No concurrent rifampin

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting

Study chairs or principal investigators

Richard Zaino, MD,  Study Chair,  Milton S. Hershey Medical Center   
Harrison George Ball, MD,  Levine Cancer Center at UMASS Memorial Campus   

Study ID Numbers:  CDR0000306440; GOG-0211; NCT00064025
Record last reviewed:  December 2004
Last Updated:  March 10, 2005
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064025
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08