An active regimen of weekly XXXX and @entity12749 in metastatic @entity342 -independent @entity263 .

@entity1 @entity12749 @entity137 @entity263 @entity583 @entity16 @entity1311 @entity1150 @entity1398 @entity17707 @entity342 @entity236 @entity715 @entity1486
OBJECTIVES: The efficacy of weekly high-dose @entity1311 in @entity342 -independent @entity263 and its cytotoxic synergy with @entity12749 led to the evaluation of a weekly schedule of @entity1311 and @entity12749 in this Phase II trial. METHODS: @entity1 were eligible if they had metastatic @entity263 with objective progression or rising @entity1486 levels despite @entity342 deprivation therapy and @entity17707 withdrawal. Prior radiation and/or one prior chemotherapy regimen was permitted. A Zubrod performance status of 2 or less and adequate @entity236 were required. @entity12749 was administered orally at a dose of 280 mg three times daily on days 1 to 3, 8 to 10, and 15 to 17. @entity1311 (150 mg/m2) was administered as a 1-hour intravenous infusion on days 2, 9, and 16. Therapy was repeated every 28 days (one cycle). RESULTS: Twenty-eight @entity1 were enrolled (median age 71.5 years). Fifteen @entity1 had measurable disease (nine nodal and seven visceral) and 13 had bone-only metastases. A total of 116 cycles of therapy were delivered (median 4 cycles per @entity1 , range 1 to 12). Nine @entity1 required dose reduction. The predominant @entity137 consisted of grade 3 @entity16 in 6 @entity1 and grade 3 and 4 @entity1398 in 4 @entity1 , with one hospitalization for @entity1398 . Three @entity1 had @entity715 manifestations: one @entity1150 and two non-Q wave @entity583 . Of the 28 @entity1 , 26 were assessable for response. Of 13 @entity1 with measurable disease, 5 demonstrated a partial response (1 in the liver and 4 in the lymph nodes), and 8 of 13 @entity1 with bone-only metastases had a 50% or greater decrease in @entity1486 level. Three @entity1 had a 90% or greater decline in @entity1486 . The overall @entity1486 response rate was 61.53% (95% confidence interval 38.1% to 74.2%). The median time to progression was 4.64 months, and the median survival was 13 months. CONCLUSIONS: The combination of weekly @entity12749 and @entity1311 is active in metastatic @entity342 -independent @entity263 .
