Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial
brief summary
The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Researchers will also study the safety of these 2-drug sequences.
detailed description
The Study Drugs:
Everolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.
Pazopanib is designed to block a protein that may cause uncontrolled tumor growth. Blocking this protein may prevent cancer from growing and spreading.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 6 groups. There is an equal chance of being assigned to each group.
* Group 1 will receive pazopanib, possibly followed by bevacizumab. * Group 2 will receive pazopanib, possibly followed by everolimus. * Group 3 will receive everolimus, possibly followed by bevacizumab. * Group 4 will receive everolimus, possibly followed by pazopanib. * Group 5 will receive bevacizumab, possibly followed by pazopanib. * Group 6 will receive bevacizumab, possibly followed by everolimus.
If the disease gets worse while you receive your first assigned drug, you will stop taking the drug. Then if you are not having side effects, you will start taking your second assigned drug 2-4 weeks later.
Everolimus is taken by mouth 1 time per day (at about the same time each day).
Bevacizumab is given by vein over 30-90 minutes, 1 time every 2 weeks.
Pazopanib is taken by mouth 1 time per day (at about the same time each day on an empty stomach).
You may be able to receive the bevacizumab doses at your local doctor's office. Ask your study doctor about this.
Study Visits:
Every week during Weeks 1-4, your blood pressure will be checked (either at home, at the clinic, or by your local doctor) if you are taking pazopanib or bevacizumab. If you are checking your own blood pressure at home, you should keep a log to write down your blood pressure. Bring the log to your next clinic visit.