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

NCT03671811 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: 17327NCI-2018-01555P30CA033572
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atypical Endometrial Hyperplasia; Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Tumor Ki-67 Proliferation Index

  Ki-67 represents a specific nuclear marker for cell proliferation that is measured by staining with specific antibodies by immunohistochemical (IHC) staining. The Ki-67 proliferation index is defined as percent tumor cells staining positive, and measured on a continuous scale of 0-100%, with higher values indicating higher proliferation. Ki-67 hotspot values were assessed at two time-points during this study, prior to treatment with megace +/- pterostilbene (pre-treatment), and following completion of treatment (post-treatment). Descriptive statistics were used to compare treatment-associated percent change in Ki-67 proliferation index between the 2 study arms, using a 1-sided test with significance at p \< 0.05.

  Pre- and post-treatment up to 6 weeks

Secondary Outcomes (6)

• Histologic Response of Gland Cellularity

  Up to 6 weeks

• Histologic Response of Mitotic Index

  Up to 6 weeks

• Histologic Response of Metaplasia

  Up to 6 weeks

• Histologic Response of Eosinophilic Metaplasia

  Up to 6 weeks

• Immunohistochemical Expression of Bcl-2 to Assess Tumor Growth and Apoptosis

  Pre- and post-treatment up to 6 weeks

Study Arms (2)

Arm I (pterostilbene, megestrol acetate)

EXPERIMENTAL

Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.

Drug: Megestrol Acetate; Biological: Pterostilbene

Arm II (megestrol acetate)

EXPERIMENTAL

Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity.

Drug: Megestrol Acetate

Interventions

Megestrol Acetate DRUG

Given PO

Also known as: 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate, 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione, 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone, 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone, BDH 1298, BDH-1298, Maygace, Megace, Megestat, Megestil, Niagestin, Ovaban, Pallace, SC-10363

Arm I (pterostilbene, megestrol acetate); Arm II (megestrol acetate)

Pterostilbene BIOLOGICAL

Given PO

Also known as: 3'',5''-Dimethoxy-4-stilbenol, 3,5-Dimethoxy-4''-hydroxystilbene, Trans-3,5-dimethoxy-4-hydroxystilbene

Arm I (pterostilbene, megestrol acetate)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 quercetin
• Chemotherapy for EC
• Allergic reaction/hypersensitivity to similar agents, excipients
• Unstable cardiac disease as defined by one of the following:
• Cardiac events such as myocardial infarction (MI) within the past 6 months
• NYHA (New York Heart Association) heart failure class III-IV
• Uncontrolled atrial fibrillation or hypertensive emergency/urgency (defined as systolic blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 120 mmHg)
• Active or history of recent thromboembolism or stroke, within the past 6 months
• Cushing's syndrome
• Acute infection requiring systemic (intravenous) treatment
• Known history of human immunodeficiency virus (HIV) infection
• Known active hepatitis B or C infection
• Inability to swallow tablets/capsules
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Interventions

Megestrol Acetate; Pterocarpus marsupium; 3,5-dimethoxy-4'-hydroxystilbene

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

6262185265

Study Officials

• Thanh H Dellinger

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: September 14, 2018
• Study Start: January 21, 2019
• Primary Completion: December 12, 2022
• Study Completion: March 30, 2026
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

US (1)