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
4 other identifiers
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2003
CompletedFirst Posted
Study publicly available on registry
July 9, 2003
CompletedStudy Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedApril 11, 2016
March 1, 2016
6.4 years
July 8, 2003
January 31, 2014
March 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
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.
During the hysterectomy, which is 21-24 days after administration of depo-provera
Secondary Outcomes (2)
Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression
During the hysterectomy, which is 21-24 days after administration of depo-provera
Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression
During the hysterectomy , which is 21-24 days after administration of depo-provera
Study Arms (1)
Treatment (medroxyprogesterone)
EXPERIMENTALPatients 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.
Interventions
Undergo surgical hysterectomy
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jessalyn Reboy
- Organization
- Gynecologic Oncology Group Statistical and Data Center
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Zaino
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2003
First Posted
July 9, 2003
Study Start
April 1, 2004
Primary Completion
September 1, 2010
Last Updated
April 11, 2016
Results First Posted
August 15, 2014
Record last verified: 2016-03