Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Endometrial Adenosquamous Carcinoma | Endometrial Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation | Endometrial Endometrioid Adenocarcinoma, Variant with Squamous Differentiation | ONTOLOGY_EXACT | 0.98 |
| Recurrent Uterine Corpus Carcinoma | — | UNRESOLVED | — |
| Stage III Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Medroxyprogesterone | Drug | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (medroxyprogesterone)
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Drug: Medroxyprogesterone
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
- timeFrame
- During the hysterectomy, which is 21-24 days after administration of depo-provera
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 rifampinReferences
Publications (0)
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