Ovarian Cancer Clinical Trial

Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks prior to registration; central pathology review will be required as part of the study but not for registration purposes
History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1); further protocol-specific assessments
The trial is open only to 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; the patient must be considered a suitable surgical candidate
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 within 28 days prior to registration
Formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage must be submitted along with the corresponding pathology report
Platelets >= 100,000/ul
Granulocytes (ANC) >= 1,500/ul
Creatinine =< 1.6 mg/dl
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limits of normal
Bilirubin within institutional normal limits
The patient must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry
Any patients of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

Patients with any non-endometrioid histology (such as serous, clear cell, or carcinosarcoma)
Patients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established; estrogen therapy alone is allowed
Patients with ECOG performance grade of 4
Patients with history of thrombophlebitis within the past 2 years or ongoing thromboembolic disorders
Patients who have previously received systemic, radiation or other treatment for uterine cancer
Patients for whom formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage is unavailable
Patients must not have previously received a non Food and Drug Administration (FDA) approved histone deacetylase (HDAC) inhibitor in a clinical trial setting (entinostat, belinostat)
Patients must not be currently taking or have ever taken vorinostat (Zolinza, Merck), panobinostat (Farydak, Novartis) or romidepsin (Istodax, Gloucester Pharmaceuticals)

Study is for people with:

Ovarian Cancer

Phase:

Early Phase 1

Estimated Enrollment:

50

Study ID:

NCT03018249

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 202 Locations for this study

See Locations Near You

CHI Saint Vincent Cancer Center Hot Springs
Hot Springs Arkansas, 71913, United States
John Muir Medical Center-Concord Campus
Concord California, 94520, United States
John Muir Medical Center-Walnut Creek
Walnut Creek California, 94598, United States
Rocky Mountain Cancer Centers-Aurora
Aurora Colorado, 80012, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Rocky Mountain Cancer Centers-Boulder
Boulder Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs Colorado, 80907, United States
Denver Health Medical Center
Denver Colorado, 80204, United States
National Jewish Health-Main Campus
Denver Colorado, 80206, United States
The Women's Imaging Center
Denver Colorado, 80209, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver Colorado, 80220, United States
Rose Medical Center
Denver Colorado, 80220, United States
Mercy Medical Center
Durango Colorado, 81301, United States
Southwest Oncology PC
Durango Colorado, 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood Colorado, 80113, United States
Swedish Medical Center
Englewood Colorado, 80113, United States
Mountain Blue Cancer Care Center
Golden Colorado, 80401, United States
National Jewish Health-Western Hematology Oncology
Golden Colorado, 80401, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood Colorado, 80228, United States
Saint Anthony Hospital
Lakewood Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton Colorado, 80120, United States
Littleton Adventist Hospital
Littleton Colorado, 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree Colorado, 80124, United States
Longmont United Hospital
Longmont Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont Colorado, 80501, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Parker Adventist Hospital
Parker Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo Colorado, 81008, United States
National Jewish Health-Northern Hematology Oncology
Thornton Colorado, 80260, United States
Rocky Mountain Cancer Centers-Thornton
Thornton Colorado, 80260, United States
SCL Health Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Delaware Clinical and Laboratory Physicians PA
Newark Delaware, 19713, United States
Helen F Graham Cancer Center
Newark Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford Delaware, 19973, United States
Christiana Care Health System-Wilmington Hospital
Wilmington Delaware, 19801, United States
Sacred Heart Hospital
Pensacola Florida, 32504, United States
Kootenai Medical Center
Coeur d'Alene Idaho, 83814, United States
Kootenai Cancer Center
Post Falls Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint Idaho, 83864, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest Illinois, 60045, United States
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox Illinois, 60451, United States
University of Chicago Medicine-Orland Park
Orland Park Illinois, 60462, United States
Parkview Hospital Randallia
Fort Wayne Indiana, 46805, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive Iowa, 50325, United States
Alegent Health Mercy Hospital
Council Bluffs Iowa, 51503, United States
Greater Regional Medical Center
Creston Iowa, 50801, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Mercy Medical Center-West Lakes
West Des Moines Iowa, 50266, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States
Flaget Memorial Hospital
Bardstown Kentucky, 40004, United States
Commonwealth Cancer Center-Corbin
Corbin Kentucky, 40701, United States
Saint Joseph Radiation Oncology Resource Center
Lexington Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington Kentucky, 40509, United States
Saint Joseph London
London Kentucky, 40741, United States
Jewish Hospital
Louisville Kentucky, 40202, United States
Saints Mary and Elizabeth Hospital
Louisville Kentucky, 40215, United States
Jewish Hospital Medical Center Northeast
Louisville Kentucky, 40245, United States
Jewish Hospital Medical Center South
Shepherdsville Kentucky, 40165, United States
Louisiana State University Health Science Center
New Orleans Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
Willis-Knighton Medical and Cancer Center
Shreveport Louisiana, 71103, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Health Partners Inc
Minneapolis Minnesota, 55454, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming Minnesota, 55092, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar Missouri, 65613, United States
Cox Cancer Center Branson
Branson Missouri, 65616, United States
Freeman Health System
Joplin Missouri, 64804, United States
Mercy Hospital Joplin
Joplin Missouri, 64804, United States
Delbert Day Cancer Institute at PCRMC
Rolla Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Louis Cancer and Breast Institute-South City
Saint Louis Missouri, 63109, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, United States
Mercy Hospital Washington
Washington Missouri, 63090, United States
Community Hospital of Anaconda
Anaconda Montana, 59711, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Saint Peter's Community Hospital
Helena Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Hospital
Missoula Montana, 59804, United States
CHI Health Saint Francis
Grand Island Nebraska, 68803, United States
Heartland Hematology and Oncology
Kearney Nebraska, 68845, United States
CHI Health Good Samaritan
Kearney Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln Nebraska, 68510, United States
Alegent Health Immanuel Medical Center
Omaha Nebraska, 68122, United States
Hematology and Oncology Consultants PC
Omaha Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha Nebraska, 68130, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
Midlands Community Hospital
Papillion Nebraska, 68046, United States
Women's Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Women's Cancer Care Associates LLC
Albany New York, 12208, United States
State University of New York Downstate Medical Center
Brooklyn New York, 11203, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
University of Rochester
Rochester New York, 14642, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Strecker Cancer Center-Belpre
Belpre Ohio, 45714, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Good Samaritan Hospital - Cincinnati
Cincinnati Ohio, 45220, United States
Bethesda North Hospital
Cincinnati Ohio, 45242, United States
TriHealth Cancer Institute-Westside
Cincinnati Ohio, 45247, United States
TriHealth Cancer Institute-Anderson
Cincinnati Ohio, 45255, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Mount Carmel East Hospital
Columbus Ohio, 43213, United States
Columbus Oncology and Hematology Associates Inc
Columbus Ohio, 43214, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Grant Medical Center
Columbus Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus Ohio, 43219, United States
Mount Carmel Health Center West
Columbus Ohio, 43222, United States
Doctors Hospital
Columbus Ohio, 43228, United States
Delaware Health Center-Grady Cancer Center
Delaware Ohio, 43015, United States
Delaware Radiation Oncology
Delaware Ohio, 43015, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
OhioHealth Mansfield Hospital
Mansfield Ohio, 44903, United States
Marietta Memorial Hospital
Marietta Ohio, 45750, United States
OhioHealth Marion General Hospital
Marion Ohio, 43302, United States
Knox Community Hospital
Mount Vernon Ohio, 43050, United States
Licking Memorial Hospital
Newark Ohio, 43055, United States
Newark Radiation Oncology
Newark Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth Ohio, 45662, United States
Saint Ann's Hospital
Westerville Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City Oklahoma, 73120, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
UPMC-Heritage Valley Health System Beaver
Beaver Pennsylvania, 15009, United States
Christiana Care Health System-Concord Health Center
Chadds Ford Pennsylvania, 19317, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg Pennsylvania, 15601, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton Pennsylvania, 18201, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown Pennsylvania, 15901, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport Pennsylvania, 15132, United States
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon Pennsylvania, 15108, United States
UPMC-Magee Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
UPMC-Presbyterian Hospital
Pittsburgh Pennsylvania, 15213, United States
UPMC-Saint Margaret
Pittsburgh Pennsylvania, 15215, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh Pennsylvania, 15243, United States
Geisinger Cancer Services-Pottsville
Pottsville Pennsylvania, 17901, United States
Community Medical Center
Scranton Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove Pennsylvania, 17870, United States
UPMC Cancer Center at UPMC Northwest
Seneca Pennsylvania, 16346, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
UPMC Uniontown Hospital Radiation Oncology
Uniontown Pennsylvania, 15401, United States
UPMC Washington Hospital Radiation Oncology
Washington Pennsylvania, 15301, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States
Women and Infants Hospital
Providence Rhode Island, 02905, United States
Prisma Health Cancer Institute - Laurens
Clinton South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
Prisma Health Cancer Institute - Spartanburg
Spartanburg South Carolina, 29307, United States
Memorial Hospital
Chattanooga Tennessee, 37404, United States
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin Tennessee, 37067, United States
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson Tennessee, 37343, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville Tennessee, 37204, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
Memorial GYN Plus
Ooltewah Tennessee, 37363, United States
Saint Joseph Regional Cancer Center
Bryan Texas, 77802, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton Washington, 98310, United States
Harrison Medical Center
Bremerton Washington, 98310, United States
Highline Medical Center-Main Campus
Burien Washington, 98166, United States
Saint Elizabeth Hospital
Enumclaw Washington, 98022, United States
Saint Francis Hospital
Federal Way Washington, 98003, United States
Saint Clare Hospital
Lakewood Washington, 98499, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo Washington, 98370, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma Washington, 98405, United States
Northwest Medical Specialties PLLC
Tacoma Washington, 98405, United States
Cancer Center of Western Wisconsin
New Richmond Wisconsin, 54017, United States
Cheyenne Regional Medical Center-West
Cheyenne Wyoming, 82001, United States
Billings Clinic-Cody
Cody Wyoming, 82414, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Early Phase 1

Estimated Enrollment:

50

Study ID:

NCT03018249

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider