MAXIMUM TOLERATED SYSTEMIC EXPOSURE (MTSE) TO TOPOTECAN

本研究将评估向标准品中添加拓扑替康，首先- 卡铂和足叶乙甙一线方案治疗广泛性 SCLC分期。 基于其在SCLC中的活性及其新的作用机制， 作用，拓扑替康加卡铂和依托泊苷可 提高广泛期SCLD的缓解率和中位生存期 患者 研究目的如下：1）评价 当用于治疗时，靶向拓扑替康全身暴露的可行性 卡铂和依托泊苷联合治疗广泛性 SCLC分期。2)定义最大耐受全身暴露量（MTSE） 拓扑替康联合卡铂和依托泊苷在广泛 分期SCLC患者。3)评估缓解率，发病时间 进展和接受卡铂的患者的总生存期， 拓扑替康和依托泊苷在广泛期SCLC患者中的应用。4)到 内酯和总拓扑替康清除率与肾小球 这一患者群体的滤过率。

This study will assess the addition of topotecan to the standard, first- line regimen of carboplatin and etoposide for the treatment of extensive stage SCLC. Based on its activity in SCLC and its novel mechanism of action, the addition of topotecan to carboplatin and etoposide may improve the response rate and median survival in extensive stage SCLD patients. The study objectives are as follows: 1) To evaluate the feasibility of targeting systemic exposure of topotecan when used in combination with carboplatin and etoposide in patients with extensive stage SCLC. 2) To define the maximum tolerated systemic exposure (MTSE) of topotecan in combination with carboplatin and etopside in extensive stage SCLC patients. 3) To assess the response rate, the time to disease progression, and overall survival of patients receiving carboplatin, topotecan and etoposide in extensive stage SCLC patients. 4) To correlate lactone and total topotecan clearance with glomerular filtration rate in this patient population.