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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
This randomized surgical window trial evaluates the effect of adding entinostat to medroxyprogesterone acetate before surgery works on progesterone receptors on endometrioid endometrial tumors. Medroxyprogesterone acetate is a progesterone, a hormone produced by body normally. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving medroxyprogesterone acetate with or without entinostat may effect tumors from endometrioid endometrial cancer.
PRIMARY OBJECTIVES: I. 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. SECONDARY OBJECTIVES: I. To assess the response rate (as measured by cellular morphology and proliferation) and change in activated receptor levels with the addition of entinostat at the time of hysterectomy. OUTLINE: Two arms were randomly allocated to eligible patients with equal probability. ARM I: Patients receive medroxyprogesterone acetate intramuscularly (IM) on day 1 and undergo hysterectomy between days 21-24. ARM II: Patients receive medroxyprogesterone acetate IM on day 1 and entinostat orally (PO) on days 1, 8, and 15. Patients undergo hysterectomy between days 21-24.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Start Date
October 11, 2017
Primary Completion Date
April 18, 2018
Completion Date
March 12, 2021
Last Updated
November 16, 2021
50
ACTUAL participants
Entinostat
DRUG
Hysterectomy
PROCEDURE
Laboratory Biomarker Analysis
OTHER
Medroxyprogesterone Acetate
DRUG
Lead Sponsor
National Cancer Institute (NCI)
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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