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.
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.
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)
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There are 202 Locations for this study
Hot Springs Arkansas, 71913, United States
Concord California, 94520, United States
Walnut Creek California, 94598, United States
Aurora Colorado, 80012, United States
Aurora Colorado, 80045, United States
Boulder Colorado, 80301, United States
Boulder Colorado, 80304, United States
Colorado Springs Colorado, 80907, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80204, United States
Denver Colorado, 80206, United States
Denver Colorado, 80209, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80220, United States
Durango Colorado, 81301, United States
Durango Colorado, 81301, United States
Englewood Colorado, 80113, United States
Englewood Colorado, 80113, United States
Golden Colorado, 80401, United States
Golden Colorado, 80401, United States
Greeley Colorado, 80631, United States
Lakewood Colorado, 80228, United States
Lakewood Colorado, 80228, United States
Littleton Colorado, 80120, United States
Littleton Colorado, 80122, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
Longmont Colorado, 80501, United States
Loveland Colorado, 80539, United States
Parker Colorado, 80138, United States
Parker Colorado, 80138, United States
Pueblo Colorado, 81004, United States
Pueblo Colorado, 81008, United States
Thornton Colorado, 80260, United States
Thornton Colorado, 80260, United States
Wheat Ridge Colorado, 80033, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Newark Delaware, 19713, United States
Newark Delaware, 19713, United States
Newark Delaware, 19718, United States
Rehoboth Beach Delaware, 19971, United States
Seaford Delaware, 19973, United States
Wilmington Delaware, 19801, United States
Pensacola Florida, 32504, United States
Coeur d'Alene Idaho, 83814, United States
Post Falls Idaho, 83854, United States
Sandpoint Idaho, 83864, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Lake Forest Illinois, 60045, United States
Mount Vernon Illinois, 62864, United States
New Lenox Illinois, 60451, United States
Orland Park Illinois, 60462, United States
Fort Wayne Indiana, 46805, United States
Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Council Bluffs Iowa, 51503, United States
Creston Iowa, 50801, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Iowa City Iowa, 52242, United States
West Des Moines Iowa, 50266, United States
Kansas City Kansas, 66160, United States
Westwood Kansas, 66205, United States
Bardstown Kentucky, 40004, United States
Corbin Kentucky, 40701, United States
Lexington Kentucky, 40504, United States
Lexington Kentucky, 40509, United States
London Kentucky, 40741, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40215, United States
Louisville Kentucky, 40245, United States
Shepherdsville Kentucky, 40165, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Shreveport Louisiana, 71103, United States
Baltimore Maryland, 21204, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maple Grove Minnesota, 55369, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Minneapolis Minnesota, 55454, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Wyoming Minnesota, 55092, United States
Ballwin Missouri, 63011, United States
Bolivar Missouri, 65613, United States
Branson Missouri, 65616, United States
Joplin Missouri, 64804, United States
Joplin Missouri, 64804, United States
Rolla Missouri, 65401, United States
Rolla Missouri, 65401, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63109, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Washington Missouri, 63090, United States
Anaconda Montana, 59711, United States
Billings Montana, 59101, United States
Bozeman Montana, 59715, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59804, United States
Grand Island Nebraska, 68803, United States
Kearney Nebraska, 68845, United States
Kearney Nebraska, 68847, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68130, United States
Omaha Nebraska, 68131, United States
Papillion Nebraska, 68046, United States
Las Vegas Nevada, 89169, United States
Lebanon New Hampshire, 03756, United States
Albuquerque New Mexico, 87102, United States
Albany New York, 12208, United States
Brooklyn New York, 11203, United States
Buffalo New York, 14263, United States
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Belpre Ohio, 45714, United States
Chillicothe Ohio, 45601, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45242, United States
Cincinnati Ohio, 45247, United States
Cincinnati Ohio, 45255, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43219, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Lancaster Ohio, 43130, United States
Mansfield Ohio, 44903, United States
Marietta Ohio, 45750, United States
Marion Ohio, 43302, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Newark Ohio, 43055, United States
Portsmouth Ohio, 45662, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73120, United States
Tulsa Oklahoma, 74146, United States
Abington Pennsylvania, 19001, United States
Beaver Pennsylvania, 15009, United States
Chadds Ford Pennsylvania, 19317, United States
Danville Pennsylvania, 17822, United States
Greensburg Pennsylvania, 15601, United States
Hazleton Pennsylvania, 18201, United States
Johnstown Pennsylvania, 15901, United States
Lewisburg Pennsylvania, 17837, United States
Lewistown Pennsylvania, 17044, United States
McKeesport Pennsylvania, 15132, United States
Moon Pennsylvania, 15108, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15215, United States
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15237, United States
Pittsburgh Pennsylvania, 15243, United States
Pottsville Pennsylvania, 17901, United States
Scranton Pennsylvania, 18510, United States
Selinsgrove Pennsylvania, 17870, United States
Seneca Pennsylvania, 16346, United States
State College Pennsylvania, 16801, United States
Uniontown Pennsylvania, 15401, United States
Washington Pennsylvania, 15301, United States
Wilkes-Barre Pennsylvania, 18711, United States
Providence Rhode Island, 02905, United States
Clinton South Carolina, 29325, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29307, United States
Chattanooga Tennessee, 37404, United States
Franklin Tennessee, 37067, United States
Hixson Tennessee, 37343, United States
Nashville Tennessee, 37204, United States
Nashville Tennessee, 37232, United States
Ooltewah Tennessee, 37363, United States
Bryan Texas, 77802, United States
Charlottesville Virginia, 22908, United States
Bremerton Washington, 98310, United States
Bremerton Washington, 98310, United States
Burien Washington, 98166, United States
Enumclaw Washington, 98022, United States
Federal Way Washington, 98003, United States
Lakewood Washington, 98499, United States
Poulsbo Washington, 98370, United States
Seattle Washington, 98109, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
New Richmond Wisconsin, 54017, United States
Cheyenne Wyoming, 82001, United States
Cody Wyoming, 82414, United States
Sheridan Wyoming, 82801, United States
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