Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Unde… (NCT03671811) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
United States44 participantsStarted 2019-01-21
Plain-language summary
This phase II trial studies how well megestrol acetate with or without pterostilbene works in treating patients with endometrial cancer undergoing hysterectomy. Drugs used in chemotherapy, such as megestrol acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pterostilbene is an antioxidant found in blueberries or grapes, and it has been shown to be effective in killing tumor cells and reducing cancer burden. It is not yet known whether giving megestrol acetate with or without pterostilbene may work better in treating patients with endometrial cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Willing to undergo an intraoperative biopsy/or standard of care tissue collection during surgery, following completion of treatment with MA +/- PTE
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Histologically confirmed EC or complex atypical hyperplasia of the endometrium
* Candidate for a total hysterectomy with or without bilateral salpingo-oophorectomy
* About to initiate preoperative window period, with planned hysterectomy scheduled
* Platelets \>= 100,000/mm\^3
* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
* Total bilirubin =\< 1.5 X upper limit of normal (ULN)
* Aspartate aminotransferase (AST) =\< 1.5 x ULN
* Alanine aminotransferase (ALT) =\< 1.5 x ULN
* Creatinine clearance of \>= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
* Women of childbearing potential: negative urine or serum pregnancy test in premenopausal women. Postmenopausal women do not need to undergo a pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Exclusion Criteria:
* Pterostilbene supplements within 30 days prior to day 1 of protocol therapy
* Any of the following phytochemical-based supplements within 30 days prior to day 1 of protocol therapy: resveratrol, genistein, and q…