A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus
Principal Investigator
Linda Duska, MD
Status
Terminated
Date Opened To Accrual
August 25 2017
Date Closed to Accrual
February 09 2018
Date of Study Termination
March 12 2021
Disease Site
Gynecologic [GY]
Uterine Corpus
Phase
I
Developmental Therapeutics
No
Primary Objective
To determine whether the addition of the histone deacetylase inhibitor, entinostat, in combination with medroxyprogesterone acetate in the pre-operative setting results in up-regulation of activated progesterone receptors (PR) compared to medroxyprogesterone acetate alone.
Patient Population
Women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) who are planned and appropriate for primary surgical treatment to include removal of the uterine corpus via any surgical modality.
Target Accrual
50
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.