Treatment Protocol for Patients Continuing From SU011248 Protocols
To provide access to SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol. Because this is a continuation protocol for different studies, the population will consist of patients with different solid advanced malignancies treated with a variety of therapies including single agent SU011248 and in combination with chemotherapy, and placebo (patients who did not qualify for cross-over within the previous trial due to declining health status).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Treatment Protocol for Patients Continuing From SU011248 Protocols|
- 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. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: SU011248
SU011248 50 mg by mouth daily.
50 mg by mouth daily
Other Name: Sunitinib
Hide Detailed Description
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 routine tests.
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.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amado Zurita, MD||M.D. Anderson Cancer Center|