A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take metformin before
you begin the regular study cycles (Cycles 1 and beyond). This will be called "Cycle 0."
You will take metformin by mouth 1 time a day on Days 1-4 of Cycle 0 and then 2 times a day
(about 12 hours apart) every day after that. You will take metformin for 7-10 days in Cycle
0 before Cycle 1 begins. In Cycles 1 and beyond, you will take all 3 drugs at a time. You
should take metformin with food.
Starting in Cycle 1, you will take everolimus 1 time a day by mouth at about the same time
every day. You should take it either consistently with food every day or consistently
without food every day.
Starting in Cycle 1, you will take letrozole 1 time a day by mouth at about the same time
every day.
It is very important for you to take the study drugs just as the study doctor tells you. Do
not skip any doses unless your study doctor tells you to skip doses. If you throw up after
taking the study drugs, you should NOT take another tablet that day. Let your study doctor
know that you got sick. If you forget to take the study drugs one day, do not take any
extra doses the next day. Call your study doctor and ask for advice.
There are 4 weeks in each cycle (except Cycle 0).
Study Visits:
Every cycle (+/- 10 days):
- You will have a physical exam, including measurement of your vital signs and weight.
This will include a pelvic exam if the disease can be felt in the pelvis.
- Your performance status will be recorded.
- You will be asked about any side effects you may have had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for
hepatitis.
After Cycles 2, 4, and 6 and then every 3 cycles after that (Cycles 9, 12, 15, and so on)
(+/- 10 days):
- You will have scans such as a CT scan and/or MRI to check the status of the disease.
- If you have chest disease, you will have a chest x-ray.
Length of Treatment:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
End-of-Treatment Visit:
After you are finished taking the study drugs:
- You will have a physical exam, including a pelvic exam and measurement of your vital
signs and weight.
- Your performance status will be recorded.
- You will be asked about any side effects you may have had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have scans such as a CT scan and/or MRI to check the status of the disease.
- If you have chest disease, you will have a chest x-ray.
Follow-Up Visits:
You will have follow-up visits as often as the doctor thinks is needed. At every visit:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may have had.
- If the doctor thinks it is needed, you will have scans such as a CT scan and/or MRI to
check the status of the disease.
- If you have chest disease, you will have a chest x-ray.
This is an investigational study. Everolimus is FDA approved and commercially available to
treat kidney, breast, and pancreatic cancers. Letrozole is FDA approved and commercially
available to treat breast cancer and ovarian cancer. Metformin is FDA approved and
commercially available to treat diabetes. The combination of everolimus, metformin, and
letrozole in this study to treat endometrial cancer is investigational.
Up to 47 patients will be enrolled in this study. All will take part at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR) determined by combining the complete response rate, partial response rate, and stable disease rate. Response evaluated by repeat imaging (CT or MRI) using RECIST 1.1 at the completion of the second cycle (8 weeks + 7 days of treatment).
8 weeks
No
Pamela Soliman, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0543
NCT01797523
August 2013
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |