CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Medroxyprogesterone +2 moredrug
Likely dose
Medroxyprogesterone given IM (specific dose not stated)AI-extracted
Key inclusion· 2
  • ✓Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus, all grades and stages eligible
  • ✓Diagnosis by endometrial curettage or biopsy within the past 8 weeks with tissue block or 16 unstained sections of 5 micron thickness available
Key exclusion· 7
  • ✕History of thrombophlebitis or thromboembolic disorders
  • ✕Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • ✕Prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
  • ✕Concurrent aminoglutethimide use

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00064025
NCT00064025Phase 2Completed
CompareCT.gov

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

Gynecologic Oncology Group·interventional·Posted Jul 9, 2003·Updated Apr 11, 2016

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Medroxyprogesterone, and 1 other intervention for Endometrial Adenocarcinoma and 7 related conditions. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2003
Enrollment StartApr 1, 2004
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 23.0 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Medroxyprogesteronedrug

Given IM

Therapeutic Conventional Surgeryprocedure

Undergo surgical hysterectomy