Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Richard Zaino	Gynecologic Oncology Group

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00064025 History of Changes
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
Results First Posted:	August 15, 2014
Last Update Posted:	April 11, 2016
Last Verified:	March 2016

Additional relevant MeSH terms:

Carcinoma; Adenocarcinoma; Uterine Neoplasms; Carcinoma, Endometrioid; Carcinoma, Adenosquamous; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Endometrial Neoplasms; Ovarian Neoplasms	Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Neoplasms, Complex and Mixed; Medroxyprogesterone; Medroxyprogesterone Acetate; Contraceptives, Oral, Synthetic; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Male; Antineoplastic Agents, Hormonal