Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title: A Phase II Study of Letrozole and RAD001 (Everolimus) in Patients With Advanced or Recurrent Endometrial Cancer

Status Active, not recruiting

Clinical Trial Summary

The goal of this clinical research study is to learn if the combination of RAD001 (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied.

Clinical Trial Description

The Study Drugs:

Everolimus is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.

Letrozole is designed to block chemical pathways that are necessary for tumor growth.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take 2 pills of everolimus by mouth 1 time every day. You should not open everolimus until you are about to take it because it absorbs moisture and is sensitive to light. You will also take 1 pill of letrozole by mouth 1 time every day. You should take letrozole at the same time as everolimus.

Everolimus should be taken the same time every day on an empty stomach (fasting state) or after no more than a light, fat-free meal. You should wait at least 6 hours after a eating a regular (not fat-free meal) before taking everolimus. You should not eat fatty foods for at least 1 hour after taking everolimus.

If you cannot swallow the tablets, the tablets should be dissolved in a glass of about 2 tablespoons of water just before being taken. The tablets should then be stirred gently (for a maximum of 7 minutes) until the tablets are dissolved. The contents should then be drunk. If you vomit after taking the study drug, you should not take another tablet that day. If you forgot to take the drug one day, you should not take an extra dose the next day but instead contact your doctor for advice.

You will be given a diary where you will record the pills you take each day. You must bring this diary to each visit.

While you are on study, you should avoid grapefruit, grapefruit juice, and other products containing grapefruit. There are also certain drugs you cannot take during this study. You should not take any drugs during the study without asking the study doctor first.

Study Visits:

Every 4 weeks, the following tests and procedures will be performed:

• You will have a physical exam, including measurement of your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature).

• Your performance status will be recorded.

• Blood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.

• You will asked about any side effects you have experienced.

• If the disease is in the pelvis, you will have a pelvic exam.

• If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn for hepatitis testing.

• Your pills will be counted.

At Week 8, the following tests and procedures will be performed:

• You will have a physical exam, including a pelvic exam.

• You will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.

• Any tumors will be measured. The doctor will either feel the tumor or a CT, x-ray, and/or MRI will be used.

• If the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.

• You will asked about any side effects you have experienced.

After the Week 8 Visit, you will have the following tests and procedures. (If the disease has partially or completely responded to the study drugs, these tests will be done around Week

12. If the disease is stable, these tests will be done around Week 16.)

• You will have a physical exam.

• You will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.

• Any tumors will be measured. The doctor will either feel the tumor or a CT scan, x-ray, and/or MRI will be used.

• If the disease is in your chest, you will have a chest CT and/or MRI scan to check the status of the disease.

After the Week 12 or 16 visit, every 12 weeks, the following tests and procedures will be performed:

• You will have a pelvic exam.

• You will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.

I-f the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.

Length of Study:

You may continue receiving additional cycles of study treatment. You will be taken off study if you experience intolerable side effects, the disease gets worse, the disease completely responds, or the doctor thinks it is in your best interest.

End of Treatment Visit:

Within 4 weeks after the last dose of study drugs, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:

• You will have a physical exam, including measurement of your weight and vital signs.

• You will have a pelvic exam.

• Your performance status will be recorded.

• Blood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.

• You will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.

• If the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.

• Your pills will be counted and any unused study drug will be returned.

Long Term Follow-up:

After you are off study, you will be followed by your doctor on a regular basis. How often these visits occur are up to you and your doctor. The following tests and procedures will be performed:

• You will have a physical exam, including measurement of your weight and vital signs.

• You will have a pelvic exam.

• Your performance status will be recorded.

• You will be asked if you have experienced any intolerable side effects.

• You will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.

• If the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.

This is an investigational study. Everolimus is not FDA approved or commercially available. At this time, everolimus is only being used in research. Letrozole is FDA approved and commercially available for the treatment of breast cancer and ovarian cancer. The combination of everolimus and letrozole in this study for the treatment of endometrial cancer is also investigational. Up to 42 patients will take part in the multicenter study. Up to 42 will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT01068249
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 30, 2010
• Completion date: April 30, 2028