Megestrol + Metformin for Endometrial Cancer Prevention

Palo Alto (17 mi)

Overseen byEmma Barber

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies the effect of megestrol acetate alone or in combination with metformin in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer. Megestrol acetate is a drug used to block estrogen and suppress the effects of estrogen and androgens. It is the current non-surgical treatment of endometrial intraepithelial neoplasia. Metformin is a drug that has been found to have anti-cancer properties. Giving metformin and megestrol acetate together may decrease the growth of endometrial intraepithelial neoplasia in the uterus better than megestrol alone.

Eligibility Criteria

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.

Inclusion Criteria

I am on long-term antiviral treatment for herpes.

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

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

I am 18 years old or older.

My hepatitis B virus load is undetectable with treatment.

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

Exclusion Criteria

I am not a diabetic woman taking sulfonylureas or meglitinides.

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

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

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

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

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

My cancer is active again.

Treatment Details

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.

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.

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

🇺🇸 Approved in United States as Megace for: