Phase 2
N=75
Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
Endometrial Adenocarcinoma · Endometrial Adenosquamous Carcinoma · Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation · Recurrent Uterine Corpus Carcinoma · Stage I Uterine Corpus Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00064025 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative — 62.5; 68.9 percentage of participants — p=0.701
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Medroxyprogesterone (Drug); Therapeutic Conventional Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative |
62.5; 68.9 | 0.701 |
| SECONDARY Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression |
-0.77 | <.001 sig |
| SECONDARY Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression |
-1.12 | <.001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00064025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.