A Treatment Protocol for Patients Continuing From SU011248 Protocols
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.
Before you can start treatment on this study you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will have
computerized tomography (CT) or magnetic resonance imaging (MRI) scans to check the status
of your disease. If you had scans on your previous research study (within 6 weeks), you
will not need to have these scans. Women who are able to have children will have blood
drawn (about 1 teaspoon) for a pregnancy test. To be eligible to take part in this study,
the pregnancy test must be negative.
Within 1 day of starting therapy on this study, you will have a physical exam. This will
include a review of any symptoms you are currently having and any side effects you have
experienced since your last visit on the previous research study. You will be asked about
any medications or treatments you may be taking. Blood (about 1 teaspoon) will be drawn for
If you are found to be eligible to take part in this study, you will begin taking sunitinib
malate by mouth, around the same time each day, with a glass (about 8 ounces) of water. You
should not give the medicine to anyone else and you should keep the medicine out of reach of
children. You should not make-up missed doses. The dose level of the study drug you will
receive will be based on the dose level you took in the last study. You should contact your
study doctor if you have questions about your dosing. If you are planning to have
additional procedures for the treatment of the disease, like surgery or radiation therapy,
you should tell your doctor. You will need to stop taking sunitinib malate at least 2 weeks
before surgery and restart treatment at least 2 weeks after surgery. If you are to have
radiation therapy, you should stop taking sunitinib malate 1 day before and restart
treatment 1 day afterwards.
On Day 1 and on the last day you take sunitinib malate in each cycle, you will have a
physical exam. You will be asked about any symptoms you are currently having and any side
effects you have experienced since your last visit. You will be asked about any medications
or treatments you may be taking. Blood (about 1 teaspoon) and urine will be collected for
routine tests. If you were on placebo on your previous study, or this is your first time on
sunitinib malate, you will have an ECG and a blood test (about 1 teaspoon) on Day 15 as
well. At each study visit you will return any unused medication and empty pill containers.
If you are tolerating the study drug with no severe side effects after the first 8 weeks of
treatment on this study, you will only be required to return to clinic every 6 weeks for
your follow up assessments.
If your disease did not get worse while you were on the last study or if you were on the
last study for less than 4 months, you will have CT or MRI scans every 3 months to check the
status of the disease.
You may continue receiving treatment with sunitinib malate unless the disease gets worse,
you experience unacceptable side effects, or your doctor feels that it is medically
necessary for you to be removed from the study. You can be removed from this study if you
do not follow your study schedule.
Once you are off-study, you will have an end-of-study visit. At this visit, you will have a
physical exam. You will be asked about any medications or treatments you are currently
taking and any side effects you may have experienced since your last study visit. Blood
(about 1 teaspoon) and urine will be collected for routine tests. You may have an ECG if
your doctor thinks it necessary.
If your doctor thinks it is necessary, you will have CT and MRI scans. If your previous
research study required follow-up, you will be contacted about every 2 months as part of
routine follow-up care. This will either be by telephone or clinic visits (depending on
your preference), for up to 3 years from the last dose of medication.
This is an investigational study. Sunitinib malate has been approved by the FDA for the
treatment of gastrointestinal tumors and renal cell carcinoma. Its use in this study, for
your disease, is considered investigational. About 300 patients will take part in this
multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To provide access to Sutent® (sunitinib malate) for patients having taken part in a research study using Sutent® while gathering information about long-term treatment safety and effectiveness.
Amado Zurita, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|