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Spots Global Cancer Trial Database for Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Linda R Duska

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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