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Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00064025
First received: July 8, 2003
Last updated: September 16, 2010
Last verified: September 2008
History of Changes

July 8, 2003
September 16, 2010
October 2003
September 2010   (final data collection date for primary outcome measure)
  • Histologic response [ Designated as safety issue: No ]
  • Steroid receptor status as assessed by immunohistochemistry (IHC) [ Designated as safety issue: No ]
  • Growth and apoptosis as assessed by IHC [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00064025 on ClinicalTrials.gov Archive Site
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Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
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

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

PURPOSE: This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix).

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.
Interventional
Phase 2
Primary Purpose: Treatment
Endometrial Cancer
  • Drug: medroxyprogesterone
  • Genetic: microarray analysis
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
September 2010   (final data collection date for primary outcome measure)

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 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064025
CDR0000306440, GOG-0211
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Richard Zaino, MD Milton S. Hershey Medical Center
Investigator: Harrison G. Ball, MD Levine Cancer Center at UMass Medical Center - Memorial Campus
National Cancer Institute (NCI)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP