Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Diagnostic, Treatment | Completed | 18 and over | NCI | GOG-0211 NCT00064025 |
Objectives
- 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.
- Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.
- 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.
Entry Criteria
Disease Characteristics:
- 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
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
- No concurrent aminoglutethimide
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
- No prior cancer treatment that would preclude study therapy
- No concurrent bosentan
- No concurrent rifampin
Patient Characteristics:
Age
- 18 and over
Performance status
- GOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No history of thrombophlebitis or thromboembolic disorders
Other
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Expected Enrollment
60A total of 60 patients will be accrued for this study.
Outcomes
Primary Outcome(s)Histologic response
Steroid receptor status as assessed by immunohistochemistry (IHC)
Growth and apoptosis as assessed by IHC
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.
Trial Lead Organizations
Gynecologic Oncology Group
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| Richard Zaino, MD, Protocol chair | |
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| Harrison Ball, MD, Protocol co-chair | |
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| Registry Information | ||
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| 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 | |
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| Trial Start Date | 2003-10-14 | |
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| Trial Completion Date | 2010-09-15 | |
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| Registered in ClinicalTrials.gov | NCT00064025 | |
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| Date Submitted to PDQ | 2003-05-15 | |
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| Information Last Verified | 2008-09-03 | |
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| NCI Grant/Contract Number | CA27469 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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