Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Diagnostic, Treatment Closed 18 and over NCI GOG-0211 NCT00064025

Objectives

1. 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.
2. Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.
3. 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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No prior therapeutic progesterone or anti-estrogen 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

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

Expected Enrollment

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

Outcomes

Histologic response
Steroid receptor status as assessed by immunohistochemistry (IHC)
Growth and apoptosis as assessed by IHC

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Richard Zaino, MD, Protocol chair		Ph: 717-531-8246
Harrison Ball, MD, Protocol co-chair		Ph: 508-334-1160

Registry Information
Official Title		A Phase II Pilot Investigation Of The Relationship Of Short Term Depo-Provera (Medroxyprogesterone Acetate) Exposure To The Morphologic , Biochemical, And Molecular Changes In Primary Endometroid Adenocarcinoma of the Uterine Corpus
Trial Start Date		2003-10-14
Trial Completion Date		2004-04-11 (estimated)
Registered in ClinicalTrials.gov		NCT00064025
Date Submitted to PDQ		2003-05-15
Information Last Verified		2008-09-03
NCI Grant/Contract Number		CA27469

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