RHU MONOCLONAL ANTI VEGF ANTIBODY & CHEMO FOR SOLID MALIGNANCIES

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Angiogenesis is known to be critical in the development and progression of breast cancer and other solid tumors. Recently the growth factor VEGF (Vascular Endothelial Growth Factor) has been implicated as a crucial growth factor in cancer metastasis and growth. As such, it represents a reasonable therapeutic target for the treatment of cancer. We have previously performed the phase I trial of anti-VEGF as a single agent and now propose to assess the safety and pharmacokinetic effects of combining anti-VEGF with chemotherapy based upon pre-clinical data which suggests improved therapeutic outcome when inhibitors of angiogenesis and chemotherapy are combined. This is a two center trial and we anticipate placing approximately half the patients on study. It appears that based upon drug availability that the study may not proceed beyond the first dose level and hence we expect to study ~6 patients. In addition to standard safety evaluation, pharmacokinetic analyses of VEGF, rhuMAb VEGF, and chemotherapy will be performed, using the services of the GCRC.