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Hormone Therapy

Megestrol + Metformin for Endometrial Cancer Prevention

Phase 2

Recruiting

Led By Emma Barber

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible

Must be a candidate and accepting of surgical management of EIN with planned hysterectomy

Must not have

Women who are diabetics taking sulfonylureas and meglitinides will be excluded

Pregnant women are excluded from this study because it requires hysterectomy which is contraindicated in women who are pregnant and wish to continue the pregnancy. Additionally, megestrol acetate is a category D agent. Megestrol acetate may cause fetal harm when administered to a pregnant woman

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 days post planned procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a combination of two drugs, megestrol acetate and metformin, is more effective than megestrol acetate alone in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer.

Who is the study for?

This trial is for adults with a pre-cancerous condition of the uterus called endometrial intraepithelial neoplasia (EIN), who are planning to have a hysterectomy. They must be in good health, not pregnant, and willing to use birth control if they can have children. People with certain viral infections must be on treatment with an undetectable viral load.

What is being tested?

The study is testing whether taking megestrol acetate alone or combined with metformin prevents EIN from turning into uterine cancer better than just megestrol acetate. Participants will receive these medications before their planned surgery to remove the uterus.

What are the potential side effects?

Megestrol may cause weight gain, increased blood pressure, and blood clots. Metformin can lead to stomach issues like diarrhea and nausea, as well as a rare but serious condition called lactic acidosis especially in people who drink alcohol excessively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on long-term antiviral treatment for herpes.

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I am willing to undergo a hysterectomy for my endometrial condition.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I am 18 years old or older.

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My hepatitis B virus load is undetectable with treatment.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not a diabetic woman taking sulfonylureas or meglitinides.

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I am not pregnant as the study requires surgery and medication that could harm a fetus.

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I am not breastfeeding as it may harm my nursing infant due to my treatment.

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I am a woman with a history of alcohol use disorder.

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I am not taking dofetilide, ulipristal, carbonic anhydrase inhibitors, ranolazine, vandetanib, dolutegravir, or cimetidine.

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I have had a blood clot in my lungs, brain, arteries, or deep veins.

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My cancer is active again.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 42 days post planned procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 42 days post planned procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 42 days post planned procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Ki-67 positive cells

Secondary study objectives

Changes in protein expression

Other study objectives

Ki-67 expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (megestrol acetate, metformin hydrochloride)Experimental Treatment4 Interventions

Prior to standard of care planned procedure, patients receive megestrol acetate PO BID and metformin hydrochloride extended-release PO BID for 21-35 days (up to and including the night before planned procedure) in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on the day of planned procedure.

Group II: Arm I (megestrol acetate)Active Control3 Interventions

Prior to standard of care planned procedure, patients receive megestrol acetate PO BID for 21-35 days (up to and including the night before planned procedure) in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on the day of planned procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Megestrol Acetate

2007

Completed Phase 3

~540