Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
NCT ID: NCT00064025
Last Updated: 2016-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Laboratory Biomarker Analysis
Correlative studies
Medroxyprogesterone
Given IM
Therapeutic Conventional Surgery
Undergo surgical hysterectomy
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Medroxyprogesterone
Given IM
Therapeutic Conventional Surgery
Undergo surgical hysterectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Richard Zaino
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2012-02539
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000306440
Identifier Type: -
Identifier Source: secondary_id
GOG-0211
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0211
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0211
Identifier Type: -
Identifier Source: org_study_id
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