Megestrol Acetate + Pterostilbene for Endometrial Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Pterostilbene, Resveratrol

Disqualifiers: Unstable cardiac disease, Thromboembolism, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Thanh H. Dellinger

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for women with endometrial cancer or complex atypical hyperplasia who are fit enough for surgery (ECOG 0-2) and have normal liver and kidney function. They must be able to swallow pills, not pregnant, without serious heart conditions, infections needing IV treatment, HIV, hepatitis B/C, recent thromboembolism/stroke/MI or taking certain supplements.

Inclusion Criteria

Platelets >= 100,000/mm^3

I am a candidate for a surgery to remove my uterus, and possibly my ovaries and fallopian tubes.

I am scheduled for a hysterectomy soon.

Exclusion Criteria

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, prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

I have not taken pterostilbene supplements in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive megestrol acetate with or without pterostilbene for 3 weeks

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• Megestrol Acetate
• Pterostilbene

Trial Overview The study is testing the effectiveness of megestrol acetate (a chemotherapy drug) with or without pterostilbene (an antioxidant found in blueberries/grapes) in patients undergoing hysterectomy for endometrial cancer. It aims to determine if adding pterostilbene improves outcomes.

Participant Groups

Group I: Arm II (megestrol acetate) Experimental Treatment 1 Intervention

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

Group II: Arm I (pterostilbene, megestrol acetate) Experimental Treatment 2 Interventions

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

Megestrol Acetate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Megace for:

• Breast cancer
• Endometrial cancer
• Prostate cancer
• Appetite stimulation

Approved in European Union as Megestrol for:

• Breast cancer
• Endometrial cancer
• Prostate cancer
• Appetite stimulation

Approved in Canada as Megace for:

• Breast cancer
• Endometrial cancer
• Prostate cancer
• Appetite stimulation

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+