Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
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Purpose
| Condition | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ] [ Designated as safety issue: No ]
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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 75 |
| Study Start Date: | April 2004 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00064025
| United States, Pennsylvania | |
| Gynecologic Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| Principal Investigator: | Richard Zaino | Gynecologic Oncology Group |
More Information
| Responsible Party: | Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00064025 History of Changes |
| Other Study ID Numbers: | GOG-0211 NCI-2012-02539 CDR0000306440 GOG-0211 GOG-0211 U10CA027469 |
| Study First Received: | July 8, 2003 |
| Results First Received: | January 31, 2014 |
| Last Updated: | March 17, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 Acetate Medroxyprogesterone Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptives, Oral, Synthetic |
ClinicalTrials.gov processed this record on September 26, 2016