RHU MONOCLONAL ANTI VEGF ANTIBODY & CHEMO FOR SOLID MALIGNANCIES

血管生成在乳腺癌和其他实体肿瘤的发生发展中起着至关重要的作用。近年来，生长因子VEGF（血管内皮生长因子）被认为是肿瘤转移和生长的重要生长因子。因此，它代表了治疗癌症的一个合理的治疗靶点。我们之前已经将抗vegf作为单一药物进行了I期试验，现在我们建议根据临床前数据评估抗vegf与化疗联合使用的安全性和药代动力学效应，这些数据表明，当血管生成抑制剂和化疗联合使用时，治疗效果会得到改善。这是一个两个中心的试验，我们预计将大约一半的患者纳入研究。根据药物可用性，该研究可能不会超过首次剂量水平，因此我们预计研究约6名患者。除了标准的安全性评估外，还将使用GCRC的服务进行VEGF、rhuMAb VEGF和化疗的药代动力学分析。

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.