A phase II study of XXXX by fixed-dose rate infusion, @entity900 , and @entity12698 in metastatic @entity788 .

@entity1 @entity788 @entity12698 @entity137 @entity417 @entity882 @entity900 @entity1398 @entity3840 @entity136 @entity204
UNASSIGNED: 4120 Background: The @entity3840 ( @entity3840 ) enzyme is overexpressed in 45-72% of @entity788 . Inhibition of the @entity3840 sensitises @entity1 @entity788 cells to the apoptotic effects of cytotoxic. @entity136 by fixed dose rate infusion may improve response rate and survival in @entity1 with @entity788 . This phase II study was undertaken to determine the effects of adding @entity12698 to a regimen of @entity136 by fixed dose rate infusion and @entity900 . METHODS: The primary endpoint was survival at 6 months in @entity1 with metastatic @entity788 treated with the @entity136 , @entity900 , and @entity12698 regimen. Previously untreated @entity1 with a performance status of 0-2 were eligible for this study. @entity1 received @entity136 1,000 mg/m(2) by fixed dose rate (10 mg/m(2)/min) I.V. infusion, and @entity900 35 mg/m(2) on days 1 and 8 of a 21-day cycle. @entity12698 was administered at a dose 400 mg twice-daily continuously starting day -7 until termination from study. RESULTS: A total of 22 @entity1 (median age 59 years; males 13%) were enrolled on the study. Median performance status was 1. The median number of cycles administered was 2 (range 0-11). Seventeen @entity1 were response evaluable. In intent to treat analysis, objective response and stable disease were seen in 9% (90% CI; 0.02-0.24) and 27%, respectively. Nine @entity1 were alive at 6-months. Median overall survival time was 5.7 months (90% CI; 3.7-7.5 months). No treatment related @entity204 were observed. The most commonly reported grade 3/4 @entity137 were @entity1398 (65%), @entity882 (55%), and @entity417 (35%). The majority of the @entity1 required dose reductions of @entity136 and @entity900 . CONCLUSION: @entity12698 can be safely administered in combination with @entity136 and @entity900 . The regimen of @entity136 by the fixed dose rate infusion and @entity900 was associated with significant myelosuppression. The addition of @entity12698 to a regimen utilizing @entity136 by fixed dose rate infusion did not appear to have a significant impact on the 6-month survival rate and overall survival. No significant financial relationships to disclose.
