A phase II study of XXXX in advanced metastatic @entity1358 .

@entity1 @entity137 @entity7 @entity2816 @entity2147 @entity1358 @entity1655 @entity1199 @entity1142
OBJECTIVES: To evaluate the @entity137 and activity of @entity2816 in @entity1 with advanced metastatic @entity1358 and to measure changes of one angiogenic factor, vascular endothelial growth factor ( @entity7 )165, with therapy. @entity1 AND METHODS: 29 @entity1 were enrolled on a study of @entity2816 using an intra- @entity1 dose escalation schedule. @entity1 began @entity2816 at 400 mg/d and escalated as tolerated to 1200 mg/d by day 54. Fifty-nine per cent of @entity1 had had previous therapy with @entity1199 and 52% were performance status 2 or 3. Systemic plasma @entity1655 levels were measured by dual monoclonal ELISA in 8 @entity1 . RESULTS: 24 @entity1 were evaluable for response with one partial response of 11 months duration of a @entity1 with hepatic and pulmonary metastases (4%), one minor response, and 2 @entity1 stable for over 6 months. @entity2147 and @entity1142 were prominent @entity137 and most @entity1 could not tolerate the 1200 mg/day dose level. Systemic plasma @entity1655 levels did not change with therapy. CONCLUSION: These results are consistent with a low level of activity of @entity2816 in @entity1358 . Administration of doses over 800 mg/day was difficult to achieve in this @entity1 population, however lower doses were practical. The dose-response relationship, if any, of @entity2816 for @entity1358 is unclear.
