Everolimus Versus Sunitinib Therapy in Patients With Advanced Non-clear Cell Renal Cell Carcinoma
The Study Drugs:
Everolimus is designed to stop 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.
Sunitinib is designed to block pathways that control important events (such as the growth of
blood vessels) that are essential for the growth of cancer.
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to 1 of 2 groups.
- If you are assigned to Group 1, you will take 2 everolimus tablets by mouth once every
- If you are assigned to Group 2, you will take sunitinib capsules by mouth every day for
4 weeks, followed by 2 weeks off.
If you have any side effects from any of the drugs, tell the study doctor right away. The
study doctor may then lower the dose or keep the dose level the same.
Every 6 weeks on this study is called a study "cycle."
If the disease gets worse or you have intolerable side effects while you are on study, you
will have the chance to receive the study drug that you did not receive at first. The dosing
and follow-up will be the same as for all participants in that group.
On Day 1 of every cycle:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any drugs or treatments you may be receiving.
- Your performance status will be recorded.
- Blood (about 3 teaspoons) and urine will be collected for routine tests and a fasting
blood sugar test. Blood or urine will also be used for a pregnancy test for women who
are able to have children. If you are in Group 1, you will have an additional 1
teaspoon of blood drawn to test your cholesterol.
On Day 15 and 29 of Cycle 1:
- Your vital signs and weight will be measured.
- Blood (about 2 teaspoons) will be drawn for routine tests. If you are in Group 1, an
additional 1 teaspoon of blood will be drawn to measure your cholesterol.
The Day 15 and Day 29 tests may be done at your local doctor's office.
On Day 1 of Cycles 1 and 2, and every other cycle after that (Day 1 of Cycle 4, 6, 8 and so
-You will have a CT scan of the chest and a CT scan or MRI of the abdomen to check the
status of the disease.
Every 4 cycles (24 weeks):
-If you are in Group 2, you will have an echocardiogram or MUGA scan to check your heart's
Length of Study:
You may continue taking the study drugs for as long as you are benefiting. You will be
taken off study if the disease gets worse or intolerable side effects occur.
If you have stopped taking the study drug because of intolerable side effects, the treating
physician will make every effort to check the status of the disease before you are taken off
Once you are no longer on this study, the research staff will check up on you about every 6
months. This update will consist of a phone call or a review of your medical and/or other
records. You will not have any extra tests, procedures, or study visits. If contacted by
phone, the call would only last about 5 minutes.
This is an investigational study. Sunitinib and everolimus are both FDA approved and
commercially available for the treatment of advanced kidney cancer.
Up to 108 patients will be enrolled in this multicenter trial. Up to 80 patients will be
enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Beginning of every 6 week cycle from baseline to disease progression or intolerable side effects.
Nizar M. Tannir, MD, FACP
UT MD Anderson Cancer Center
United States: Institutional Review Board
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