Study on Letrozole and RAD001 for Advanced or Recurrent Endometrial Cancer

Program Overview

The purpose of this study is to find out if using RAD001 (everolimus) and Femara (letrozole) together can help manage endometrial cancer that has come back or is getting worse. Researchers will also look at how safe this combination is for patients.

Description

Study Drugs:

• Everolimus: This drug is designed to stop cancer cells from growing and may also prevent new blood vessels from forming, which can help kill tumor cells.
• Letrozole: This drug works by blocking pathways that tumors need to grow.

How to Take the Study Drugs:

• If you join the study, you will take 2 pills of everolimus by mouth once a day. Do not open the pills until you are ready to take them, as they are sensitive to light and moisture.
• You will also take 1 pill of letrozole by mouth once a day, at the same time as everolimus.
• Everolimus should be taken at the same time every day, either on an empty stomach or after a light, fat-free meal. Avoid fatty foods for at least 1 hour after taking it.
• If you cannot swallow the pills, you can dissolve them in water and drink the mixture.
• If you vomit after taking the pills, do not take another dose that day. If you miss a dose, do not double up the next day; contact your doctor for advice.
• You will keep a diary to record your daily doses and bring it to each visit.
• Avoid grapefruit and certain medications during the study; consult your doctor before taking any new drugs.

Study Visits:

• Every 4 weeks, you will have a physical exam, blood tests, and your pills will be counted. You will also be asked about any side effects.
• At Week 8, you will have additional scans to check the status of your cancer.
• After Week 8, further tests will be done every 12 weeks if your cancer is stable or responding to treatment.

Length of Study:

• You may continue treatment as long as it is beneficial and you do not experience severe side effects.

End of Treatment Visit:

• Within 4 weeks after your last dose, you will have a final visit with exams and tests to check your health.

Long Term Follow-up:

• After the study, you will have regular check-ups with your doctor to monitor your health.

Investigational Status:

• Everolimus is not yet FDA approved for this use and is only available through research. Letrozole is FDA approved for breast and ovarian cancer, but their combination for endometrial cancer is investigational. Up to 42 patients will participate in this study.

Eligibility Criteria

Locations