Phase II trial of single-agent weekly XXXX in hormone-refractory, symptomatic, metastatic @entity263 .

@entity1 @entity137 @entity263 @entity5 @entity1205 @entity1486
The purpose of this study was to assess the efficacy of weekly administration of @entity1205 as a single agent in @entity1 with hormone-refractory, symptomatic, @entity263 with respect to symptom palliation, @entity5 response, time to progression, and survival. Sixty @entity1 with progressive @entity263 that had progressed on at least one hormonal regimen were enrolled in this multicenter phase II study. Twenty-one percent of @entity1 had received prior palliative radiotherapy, and 25% had received prior chemotherapy for hormone-refractory disease. @entity1 were scheduled to receive three 8-week cycles of @entity1205 (36 mg/m(2) on days 1, 8, 15, 22, 29, and 36) with 2-week intervals between cycles. The @entity1205 dose could be decreased in the event of @entity137 , but no dose escalation was permitted. A > or =50% decrease in serum @entity1486 ( @entity1486 ) levels from baseline with stabilization or improvement of performance status lasting 2 months or longer occurred in 24 (41%) @entity1 , of whom 16 (27%) had a > or =80% decrease for 2 months or more. The median time to progression for all @entity1 was 5.1 months (range, 0.9 to 18.2 months). The estimated median time to progression for @entity1 who had and those who did not have a > or =50% reduction in serum @entity1486 level with stable or improved performance status was 6.65 and 4.3 months, respectively. The median overall survival was 9.4 months (range, 1.6 to 18.2 months). Treatment @entity137 was considered acceptable. Single-agent @entity1205 at 36 mg/m(2) weekly was associated with a @entity1486 response rate of 41%, increased time to progression and survival, and minimal myelosuppression in @entity1 with hormone-refractory @entity263 .
