Kidney Cancer Clinical Trial
Official title:
A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients
The purpose of this study is to test the safety of bevacizumab and sunitinib given in combination for kidney cancer. The drugs act to stop blood vessel growth but in different ways. They have not been studied together in a previous study. We also want to find out what effects (good and bad) the combination of bevacizumab and sunitinib have on you and your tumor.
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib
administered in combination with bevacizumab for the treatment of patients with metastatic
renal cell carcinoma.
To assess antitumor activity of the combination of sunitinib and bevacizumab. To evaluate
serum levels of vascular endothelial growth factor (VEGF) in patients treated with sunitinib
and bevacizumab.
Study Design: This is a single center, open-label, Phase 1 study of sunitinib in combination
with bevacizumab in patients with advanced metastatic renal cell carcinoma. This study is
designed to confirm that the two agents can be administered safely in combination. Patients
will begin treatment with bevacizumab on Day 0 and sunitinib on Day 1. Bevacizumab will be
administered intravenously every two weeks. Sunitinib will be given orally on a 4 weeks on,
2 weeks off schedule. DLT determination will be based on toxicities observed in Cycles 1 - a
cycle is defined by sunitinib dosing (6 weeks). Once the MTD for the combination has been
identified, 10 additional patients will be enrolled at the MTD to further assess safety and
efficacy. Patients will be treated with bevacizumab and sunitinib until there is disease
progression, significant toxicity or withdrawal of patient consent. The maximum treatment
duration is 24 months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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