A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMab VEGF (Bevacizumab) for Renal Cell Carcinoma
Bevacizumab is a drug that binds to and inhibits VEGF, a blood-vessel stimulating agent with
unusually high levels in kidney cancer. This drug may decrease the growth of kidney cancer.
Every two week study cycle, you will receive a dose of bevacizumab intravenously (through a
needle in your vein). The first bevacizumab dose will be given over 90 minutes as a
continuous IV infusion. If the first dose is tolerated without any side effects related to
the intravenous (IV) infusion, the second dose may be delivered over 60 minutes. If the 60
minute infusion is tolerated, all doses of bevacizumab after that may be given over 30
minutes. If you experience infusion-related side effects with the 60 minute infusion, all
doses after that will be given over 90 minutes. If you experience infusion-related side
effects with the 30 minute infusion, all doses after that will be given over 60 minutes.
Other drugs, including Tylenol and Benadryl, may be given before, during, and after the
therapy to help prevent or ease side effects. These drugs may be given either by mouth or
through an IV line.
During treatment, blood samples (about 1 1/2 tablespoons) will be taken once per 2 week
cycle. Urine samples will be taken at the beginning of each cycle. At around 56 days into
treatment, tumors will be measured using X-rays or other scans.
Treatment will be stopped after 56 days of therapy. In this first phase, you will receive 4
doses of bevacizumab.
If the cancer is stable or shrinks while on bevacizumab for the first 56 days, and you
tolerated the treatment well, you will undergo surgery to remove your kidney tumor. Surgery
will be scheduled at least 4 weeks after your last dose of bevacizumab. Approximately 4
weeks after surgery, you will undergo repeat CT scans. If your cancer is stable or
continuing to shrink, you will restart treatment with bevacizumab. You will continue to
have tumor measurements by scans around every 56 days (8 weeks) while receiving bevacizumab,
if your initial scans showed evidence of tumor presence. However, If your tumor grew
substantially during the operative period, i.e. between the first set of scans on or around
day 56 and the scans performed after surgery, you will be taken off the study, and other
treatments will be offered to you.
If the cancer grew while on bevacizumab for the first 56 days, you will undergo surgery to
remove your kidney tumor. Surgery will be scheduled at least 4 weeks after your last dose
of Bevacizumab. After surgery, you will not continue on bevacizumab. Once you recover from
surgery, your doctor may recommend a different drug therapy to treat your cancer.
In some circumstances, after the first 56 days of therapy with bevacizumab, your doctors may
decide that it is not possible or helpful for your kidney to be removed because of
progression of your cancer rendering such an operation either not feasible or inappropriate
for your care. In that case, your doctors may recommend a different drug therapy for your
cancer, and you will not continue on bevacizumab.
You may be taken off study if your disease progresses or intolerable side effects occur.
If you are taken off study, you will have repeat scans, a physical examination, blood
testing (about 2 tablespoons), urine testing, and an ECG. If you have elevated blood
pressure or excess protein in your urine, you will be asked to come back every 2 months for
repeat blood pressure testing and urine testing until these levels fall to a normal range,
for up to one year.
This is an investigational study. Avastin is commercially available and approved by the FDA
for metastatic colorectal cancer and small cell lung cancer. The drug is experimental and
authorized for research purposes only in renal cell carcinoma. Up to 50 participants will
take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
Efficacy of neoadjuvant therapy of bevacizumab by progression of disease after first 56 days of therapy.
Eric Jonasch, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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