Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer
Completed · Early Phase 1
Conditions studied: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 3 Endometrial Endometrioid Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT03018249
- Run by
- National Cancer Institute (NCI)
- People needed
- 50
- Starts
- 2017-10-11
- Expected to finish
- 2021-03-12
- Last updated by the study team
- 2021-11-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- 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
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
Full record on ClinicalTrials.gov
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