A Phase II trial of XXXX monthly x 3 for @entity263 .

@entity1 @entity137 @entity263 @entity1295 @entity619 @entity5747 @entity1486
BACKGROUND: The goal of the current study was to determine the @entity1486 and objective response rates and the pharmacokinetics associated with a monthly x 3 one-hour infusion of @entity5747 in 58 @entity1 with @entity263 . METHODS: A @entity1486 response was defined as a > 50% reduction in the @entity1486 level from baseline for at least 3 consecutive evaluations over a minimum of 6 weeks. The @entity5747 dose was 2400 mg/m(2) taken intravenously on Day 1, 1620 mg/m(2) on Day 29, and 1292 mg/m(2) on Day 57. All @entity1 received 0.5 mg @entity619 twice daily. RESULTS: Among 56 evaluable @entity1 (median entry @entity1486 level, 229.5 ng/mL), there were 21 @entity1486 responders (37.5%). Among 27 @entity1 with measurable disease, there were 5 responders (4 partial and 1 complete). The median overall survival time was 15.3 months. @entity1295 (14.1%) was the predominant @entity137 observed. @entity5747 plasma levels remained high even 3 months after treatment was discontinued. Among the 12 evaluable @entity1 who previously had received chemotherapy, the @entity1486 response rate was 42%; one response was observed among 4 @entity1 with measurable disease, and the median survival was 12 months. CONCLUSIONS: Monthly bolus @entity5747 was well tolerated, reduced @entity1486 levels, and induced objective responses, even in @entity1 who previously had received chemotherapy.
