Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma
Sunitinib malate is designed to block pathways that control important events such as the
growth of blood vessels that are essential for the growth of cancer.
If you are found to be eligible to take part in this study, you will take sunitinib malate
once a day (either with or without food) for 4 weeks in a row followed by 2 weeks of rest
with no study drug. These 6 weeks are considered 1 cycle of study treatment.
Around Day 15 of each cycle, your vital signs will be measured and recorded, and you will
have blood drawn (about 2 teaspoons) for routine testing. These evaluations can be done at
your local doctor's office.
You will be required to return to clinic for a follow-up visit around Day 29 of Cycle 1.
At this visit, your medical history will be recorded, and your ability to perform daily
activities will be evaluated. You will have a physical exam, including measurement of your
vital signs. You will be asked about any side effects you may have experienced since your
last visit. You will be asked about any medicines you may be currently taking. You will
have blood drawn (about 4 teaspoons) for routine testing.
Beginning Day 1 of Cycle 3, you will return to clinic every 12 weeks (Day 1 of each cycle).
You will have the same evaluations as you did at the Day 29 visit.
On Day 1 of every other cycle, you will have an ECG and a doppler echocardiogram or MUGA
scan to evaluate your heart health.
You will have follow-up imaging scans (CT and/or MRI) to track your response to treatment on
Day 1 of the first 2 cycles and every 12 weeks thereafter for as long as you are receiving
treatment on this study.
You will continue to receive treatment on this study, unless your disease gets worse, you
develop an illness that prevents you from continuing treatment, or you experience any
intolerable side effects of the study drug. You will be removed from this study if any of
these circumstances occur.
This is an investigational study. Sunitinib malate has been authorized by the FDA for
treatment of clear cell renal carcinoma. Its use in non-clear cell renal carcinoma is
experimental. Up to 60 patients will take part in this study. All will be enrolled at MD
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Activity [Response rate + Progression free survival (PFS)]
Day 1 of each 6 week cycle, 12 week evaulation
Nizar M. Tannir, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|