Phase II study of the activity and tolerability of a combined regimen of high-dose @entity1259 and XXXX in stage IIIb and IV @entity1149 .

@entity1 @entity137 @entity390 @entity1261 @entity1149 @entity1259 @entity900 @entity391 @entity33 @entity448 @entity1395 @entity1431 @entity2772
AIM: To explore the feasibility and activity of a combined regimen of high-dose @entity1259 and @entity900 as an alternative to current treatments for @entity1149 ( @entity1149 ). METHOD: Forty-four @entity1 with stage IIIb or IV @entity1149 , median Karnofsky index 90, were enrolled. @entity1259 (60 mg/m2) was administered on days 1 and 2 and @entity900 (100 mg/m2) on day 1. Treatment was repeated every 21 days for a maximum of six cycles. A @entity2772 ( @entity1261 ) was used only for @entity1 reaching codified nadir count values. RESULTS: A total of 130 cycles were administered with a mean of 2.9 cycles per @entity1 . Of 41 assessable @entity1 one showed a complete response and 15 had partial responses (overall response rate, 39%). Grade 3 or 4 @entity1431 and grade 3 hemoglobin @entity137 were seen in 40% and 14%, respectively, of the administered cycles. The most common nonhematologic toxic events were @entity390 and @entity391 , @entity33 , @entity448 , and @entity1395 . CONCLUSIONS: This @entity1259 - @entity900 regimen seemed effective and was generally well tolerated, and therefore suitable for use in an outpatient setting.
