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Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

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ClinicalTrials.gov Identifier: NCT00064025
Recruitment Status : Completed
First Posted : July 9, 2003
Results First Posted : August 15, 2014
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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Brief Summary:
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). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.

Condition or disease Intervention/treatment Phase
Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation Recurrent Uterine Corpus Carcinoma Stage I Uterine Corpus Cancer Stage II Uterine Corpus Cancer Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer Other: Laboratory Biomarker Analysis Drug: Medroxyprogesterone Procedure: Therapeutic Conventional Surgery Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

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

III. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2004
Actual Primary Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (medroxyprogesterone)

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.

 Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Medroxyprogesterone
Given IM
Other Name: Curretab

Procedure: Therapeutic Conventional Surgery
Undergo surgical hysterectomy


Outcome Measures
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Primary Outcome Measures :
  1. Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative [ Time Frame: During the hysterectomy, which is 21-24 days after administration of depo-provera ]

    To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data.

    PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area.



Secondary Outcome Measures :
  1. Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression [ Time Frame: During the hysterectomy, which is 21-24 days after administration of depo-provera ]
    Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.

  2. Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression [ Time Frame: During the hysterectomy , which is 21-24 days after administration of depo-provera ]
    Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-3
  • No history of thrombophlebitis or thromboembolic disorders
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
  • No concurrent aminoglutethimide
  • No prior cancer treatment that would preclude study therapy
  • No concurrent bosentan
  • No concurrent rifampin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064025


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Richard Zaino Gynecologic Oncology Group
More Information
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00064025    
Other Study ID Numbers: GOG-0211
NCI-2012-02539 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000306440
GOG-0211 ( Other Identifier: Gynecologic Oncology Group )
GOG-0211 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2003    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: April 11, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Carcinoma, Endometrioid
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
 Gonadal Disorders
Endocrine System Diseases
Neoplasms, Complex and Mixed
Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents