Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Everolimus Versus Sunitinib Therapy in Patients With Advanced Non-clear Cell Renal Cell Carcinoma|
- Progression-Free Survival (PFS) [ Time Frame: Beginning of every 6 week cycle from baseline to disease progression or intolerable side effects. ] [ Designated as safety issue: Yes ]Time to event endpoints descriptively summarized by Kaplan-Meier curves. Evaluation of response follows the Response Evaluation Criteria in Solid Tumors.
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: Everolimus Group 1
Everolimus 10 mg by mouth once a day.
10 mg by mouth once a day.
Active Comparator: Sunitinib Group 2
Sunitinib 50 mg by mouth daily for 4 weeks on / 2 weeks off.
50 mg by mouth daily for 4 weeks on / 2 weeks off
Hide Detailed Description
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 day.
- 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 2 and 3, and every other cycle after that (Day 1 of Cycle 5, 7, 9 and so on):
- 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 health.
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 of study.
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 108 patients will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185366
|United States, Massachusetts|
|Dana-Farber Cancer Institute/Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Huntsman Cancer Institute - University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Amado Zurita, MD||M.D. Anderson Cancer Center|