Renal Cell Cancer Clinical Trial
This research study is for subjects with cancer of the kidney (also known as renal cell
carcinoma) that cannot be treated with surgery. The purpose of this study is to see if the
combination of bevacizumab and bortezomib is safe and tolerable and can help people with
kidney cancer. The investigators would also like to find out what dose of the study drugs
can be used safely and effectively, whether the combination of these two drugs can decrease
cancer symptoms and stop tumor growth, and how frequently serious side effects might occur
with this combination.
The study will be conducted in two phases—Phase 1 and Phase 2. In Phase 1, subjects will be
assigned to a fixed dose of bevacizumab and different strengths of bortezomib given at 2
different schedules. Phase 2 will depend on how subjects tolerate the doses and schedules of
bortezomib in Phase 1.
Bortezomib is a type of drug known as a "proteasome inhibitor." By blocking the "proteasome"
in cancer cells, bortezomib affects the way these cells divide. Bevacizumab is an inhibitor
(blocker) of blood vessel formation. Tumors need blood vessels in order to continue to grow
and bevacizumab is thought to work by preventing new blood vessels from growing.
Bortezomib (also called Velcade or PS-341) has been approved by the US Food and Drug
Administration (FDA) for the treatment of myeloma, but has not been approved for the
treatment of kidney cancer. Bevacizumab (also called Avastin) has been approved by the FDA
for the treatment of colon cancer, but has not been approved for the treatment of kidney
cancer. However, the FDA is permitting the combined use of bortezomib and bevacizumab in
this research study.
The bevacizumab that will be given in this study is not a commercially marketed product.
Although it is expected to be very similar in safety and activity to the commercially
available drug, it is possible that some differences may exist. Because this is not a
commercially marketed drug, bevacizumab can only be administered to subjects enrolled in
this study and may only be administered under the direction of physicians who are
investigators in this study.
Approximately 40-52 subjects will take part in this study.
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