Solid Tumors Clinical Trial
Official title:
Phase I Combination of Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients With Advanced Solid Tumors Refractory to Standard Therapy
The goal of this clinical research study is to find the highest tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Pazopanib is designed to block different receptors in the cancer cells that ultimately are responsible for the growth of the tumor and its blood vessels. Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also involved in cancer growth.
Study Groups: Dose Escalation: If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of pazopanib and everolimus based on when you joined this study. Up to 8 dose levels of pazopanib and everolimus will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of pazopanib and everolimus is found. Expansion: Once the highest tolerable dose of pazopanib and everolimus is found, up to 14 more participants may be enrolled to further study the safety of the drugs at that dose and the efficacy of the drugs in a certain tumor group. Study Drug Administration: Each study cycle is 28 days. Pazopanib and everolimus are taken by mouth on an empty stomach (1 hour before meals or 2 hours after meals). On Days 1-5 of Cycle 1 only, you will take pazopanib and everolimus together. First take pazopanib and then take everolimus. After those first 5 days, you will take pazopanib and everolimus every other day separately. Starting Day 6 of Cycle 1, pazopanib will be taken every even day (6, 8, 10, and so on) . Everolimus will be taken every odd day (7, 9, 11, and so on). Beginning with Cycle 2, you will take pazopanib every even day (2, 4, 6, and on so) and everolimus every odd day (3, 5, 7, and so on). Study Visits: At each study visit, you will be asked what about any drugs or herbal supplements that you may be taking and if you have had any side effects. On Day 1 of Cycle 1: - Your medical history will be recorded if it has been more than 3 days since screening. - You will have a physical exam, including measurement of your weight and vital signs. - Your performance status will be recorded. - You will have an ECG. - Blood (about 2 teaspoons) and urine will be collected for routine tests and hepatitis screening. On Days 8, 15, and 22 of Cycle 1: - You will have a physical exam, including measurement of your weight and vital signs. - Blood (about 2 teaspoons) and urine will be collected for routine tests. On Day 1 of Cycles 2 and beyond: - You will have a physical exam, including measurement of your weight and vital signs. - Your performance status will be recorded. - Blood (about 2 teaspoons) and urine will be collected for routine tests. - You will have an ECG. On Day 15 of Cycle 2: ° Blood (about 2 teaspoons) will be collected for routine tests. Every 8 weeks: - You will have a CT scan, x-ray, MRI scan, and/or PET scan to check the status of the disease. - Blood (about 1 teaspoon) may be drawn for tumor marker testing. - If you are able to become pregnant, you will have a blood (about ½ teaspoon) or urine pregnancy test. PK testing: At least 6 participants in the expansion part of the study will have blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing. The study staff will tell you if you will have this testing. PK testing measures the amount of study drug in the body at different time points. - On Day 5 of Cycle 1 and Days 1 and 2 of Cycle 2, blood will be drawn before and 8 more times up to 10 hours after taking the study drugs. - On Day 2 of Cycle 2, blood will be drawn 1 more time for PK testing after 24 hours of taking everolimus. If you could not have the 10 hour draw the day before, this will be drawn at this day. - On Day 6 of Cycle 1 and Day 3 of Cycle 2, blood will be drawn 1 time for PK testing after 24 hours of taking pazopanib. If you could not have the 10 hour draw the day before, this will be drawn at this day. - Blood will be drawn 1 time at the end-of-dosing visit. Length of Study: You may continue taking the study drugs for as long as you are benefitting. You will be taken off study early if the disease gets worse, intolerable side effects occur, you develop new health problems, or your doctor thinks that it is no longer in your best interest to receive the study drug. End-of-Dosing Visit: Within 4 weeks after your last dose of study drugs: - You will have a physical exam, including measurement of your weight and vital signs. - Your performance status will be recorded. - Blood (about 2 teaspoons) and urine will be collected for routine tests. - If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test. This is an investigational study. Pazopanib is FDA approved and commercially available for the treatment of advanced renal cancer and certain types of advanced soft tissue sarcoma but has not been approved for use in other cancer types. Everolimus is FDA approved and commercially available for the prevention of kidney transplant rejection, to treat advanced renal cancer, and to treat subependymal giant cell astrocytoma associated with tuberous sclerosis. The combination of pazopanib and everolimus to treat advanced cancer is investigational. Up to 62 patients will be enrolled in this study. All will be enrolled at MD Anderson. ;
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