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Brief Title: Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer
Official Title: 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
Study ID: NCT03018249
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
National Jewish Health-Main Campus, Denver, Colorado, United States
The Women's Imaging Center, Denver, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, United States
SCL Health Saint Joseph Hospital, Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Mercy Medical Center, Durango, Colorado, United States
Southwest Oncology PC, Durango, Colorado, United States
Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Mountain Blue Cancer Care Center, Golden, Colorado, United States
National Jewish Health-Western Hematology Oncology, Golden, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker, Parker, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Pueblo, Pueblo, Colorado, United States
National Jewish Health-Northern Hematology Oncology, Thornton, Colorado, United States
Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, United States
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
Beebe Medical Center, Lewes, Delaware, United States
Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States
Sacred Heart Hospital, Pensacola, Florida, United States
Kootenai Medical Center, Coeur d'Alene, Idaho, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States
Parkview Hospital Randallia, Fort Wayne, Indiana, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Mercy Cancer Center-West Lakes, Clive, Iowa, United States
Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States
Greater Regional Medical Center, Creston, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
Flaget Memorial Hospital, Bardstown, Kentucky, United States
Commonwealth Cancer Center-Corbin, Corbin, Kentucky, United States
Saint Joseph Radiation Oncology Resource Center, Lexington, Kentucky, United States
Saint Joseph Hospital East, Lexington, Kentucky, United States
Saint Joseph London, London, Kentucky, United States
Jewish Hospital, Louisville, Kentucky, United States
Saints Mary and Elizabeth Hospital, Louisville, Kentucky, United States
Jewish Hospital Medical Center Northeast, Louisville, Kentucky, United States
Jewish Hospital Medical Center South, Shepherdsville, Kentucky, United States
Louisiana State University Health Science Center, New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Willis-Knighton Medical and Cancer Center, Shreveport, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Health Partners Inc, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Fairview Lakes Medical Center, Wyoming, Minnesota, United States
Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States
Cox Cancer Center Branson, Branson, Missouri, United States
Freeman Health System, Joplin, Missouri, United States
Mercy Hospital Joplin, Joplin, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Mercy Hospital Washington, Washington, Missouri, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
CHI Health Saint Francis, Grand Island, Nebraska, United States
Heartland Hematology and Oncology, Kearney, Nebraska, United States
CHI Health Good Samaritan, Kearney, Nebraska, United States
Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Hematology and Oncology Consultants PC, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Alegent Health Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Midlands Community Hospital, Papillion, Nebraska, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Women's Cancer Care Associates LLC, Albany, New York, United States
State University of New York Downstate Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
University of Rochester, Rochester, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Strecker Cancer Center-Belpre, Belpre, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States
Bethesda North Hospital, Cincinnati, Ohio, United States
TriHealth Cancer Institute-Westside, Cincinnati, Ohio, United States
TriHealth Cancer Institute-Anderson, Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Mount Carmel East Hospital, Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Delaware Health Center-Grady Cancer Center, Delaware, Ohio, United States
Delaware Radiation Oncology, Delaware, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
OhioHealth Mansfield Hospital, Mansfield, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
OhioHealth Marion General Hospital, Marion, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Newark Radiation Oncology, Newark, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
Saint Ann's Hospital, Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
UPMC-Heritage Valley Health System Beaver, Beaver, Pennsylvania, United States
Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, United States
UPMC-Coraopolis/Heritage Valley Radiation Oncology, Moon, Pennsylvania, United States
UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Presbyterian Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Saint Margaret, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Saint Clair Hospital Cancer Center, Pittsburgh, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Community Medical Center, Scranton, Pennsylvania, United States
Geisinger Medical Oncology-Selinsgrove, Selinsgrove, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
UPMC Uniontown Hospital Radiation Oncology, Uniontown, Pennsylvania, United States
UPMC Washington Hospital Radiation Oncology, Washington, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Prisma Health Cancer Institute - Laurens, Clinton, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg, Spartanburg, South Carolina, United States
Memorial Hospital, Chattanooga, Tennessee, United States
Vanderbilt-Ingram Cancer Center Cool Springs, Franklin, Tennessee, United States
Pulmonary Medicine Center of Chattanooga-Hixson, Hixson, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Memorial GYN Plus, Ooltewah, Tennessee, United States
Saint Joseph Regional Cancer Center, Bryan, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States
Harrison Medical Center, Bremerton, Washington, United States
Highline Medical Center-Main Campus, Burien, Washington, United States
Saint Elizabeth Hospital, Enumclaw, Washington, United States
Saint Francis Hospital, Federal Way, Washington, United States
Saint Clare Hospital, Lakewood, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Franciscan Research Center-Northwest Medical Plaza, Tacoma, Washington, United States
Northwest Medical Specialties PLLC, Tacoma, Washington, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Name: Linda R Duska
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR