MAXIMUM TOLERATED SYSTEMIC EXPOSURE (MTSE) TO TOPOTECAN

这项研究将评估在卡铂和依托泊苷治疗广泛期小细胞肺癌的标准一线方案中加入拓扑替康。根据拓扑替康在小细胞肺癌中的活性及其新的作用机制，在卡铂和依托泊苷的基础上加用拓扑替康可能会提高广泛期SCLD患者的缓解率和中位生存期。研究目标如下：1)评价拓扑替康联合卡铂和依托泊苷治疗广泛期小细胞肺癌的靶向性全身暴露的可行性。2)确定广泛期小细胞肺癌患者拓扑替康联合卡铂和依托泊苷的最大耐受性全身暴露(MTSE)。3)评估卡铂、拓扑替康和依托泊苷治疗广泛期小细胞肺癌患者的有效率、疾病进展时间和总生存期。4)研究内酯和总拓扑替康清除量与肾小球滤过率之间的关系。

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.