A phase I dose escalation study of biweekly XXXX and @entity3003 in completely resected stage IB-IIIA @entity1149 .

@entity1 @entity137 @entity3003 @entity1149 @entity177 @entity1398 @entity1431 @entity136
OBJECTIVE: We conducted a phase I dose escalation study to determine the maximum tolerated dose, recommended dose, and safety profile of a biweekly @entity136 and @entity3003 combination regimen in the treatment of @entity1 with completely resected @entity1149 ( @entity1149 ). @entity1 AND METHODS: @entity1 with completely resected pathologically documented stage IB, II, or IIIA @entity1149 , performance status (ECOG) 0-1, with adequate bone marrow, @entity177 , were treated with @entity136 and @entity3003 . The starting dose was @entity136 800 mg/m2 on days 1 and 15 and @entity3003 area under the time-concentration curve (AUC) 4 mg/mL/min on day 1. @entity136 was increased to 1000 mg/m2 (level 3). @entity3003 was increased to AUC 5 (level 2, 3). The regimen was performed every 4 weeks. The dose-limiting @entity137 of the regimen was assessed during the first chemotherapy cycle. RESULTS: Nine @entity1 were enrolled in this study. All @entity1 were assessed for safety. Grade 3 @entity1431 occurred in 1 @entity1 (11%) and grade 3/4 @entity1398 occurred in 3 @entity1 (33%). No other grade 3/4 @entity137 was observed. No dose-limiting @entity137 was experienced at dose levels 1, 2, and 3 of this schedule. CONCLUSION: Maximum tolerated dose was not reached in this study. Considering treatment continuation, the recommended dose for a phase II study is @entity136 1000 mg/m2 on days 1 and 15 and @entity3003 AUC 5 on day 1, every 4 weeks. Biweekly administration of @entity136 and @entity3003 is a feasible and well-tolerated regimen for the treatment of @entity1 with completely resected @entity1149 as adjuvant chemotherapy.
