NCT03671811

Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy

Open-Label Randomized Phase II Trial of Megestrol Acetate With or Without Pterostilbene in Patients With Endometrial Cancer Scheduled for Hysterectomy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the effect of megestrol acetate (MA) plus pterostilbene (PTE) versus MA alone on tumor proliferation (Ki-67) during the preoperative window in patients with endometrial cancer (EC) who are scheduled for hysterectomy. EXPLORATORY OBJECTIVES: I. Determine the effect of MA plus PTE versus MA alone on histologic response during the preoperative window in patients with EC or endometrial complex atypical hyperplasia who are scheduled for hysterectomy. II. Explore biological characteristics of tumors to determine potential biomarkers which could select for treatment eligibility in future studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive pterostilbene orally (PO) twice daily (BID) and megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. ARM II: Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. After completion of study treatment, patients are followed up at 6 weeks.

Conditions

• Atypical Endometrial Hyperplasia
• Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	Megestrol Acetate	Given PO
BIOLOGICAL	Pterostilbene	Given PO

Timeline

• Start date: 2019-01-21
• Primary completion: 2022-12-12
• Completion: 2026-03-30
• First posted: 2018-09-14
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study