A Phase II Study of Letrozole and RAD001 (Everolimus) in Patients With Advanced or Recurrent Endometrial Cancer
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.
- If 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 Visi:t
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response or Stable Disease Rate (CR + PR + SD)
Evaluation within approximately 8 weeks of treatment, then every 12 weeks.
Yes
Robert Coleman, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0059
NCT01068249
April 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |
Morristown Memorial Hospital, Women's Cancer Center | Morristown, New Jersey 07962 |