TOPOTECAN & ETOPOSIDE IN ADVANCE NON SMALL CELL LUNG CANCER

该方案采用剂量强化化疗方案。 它利用了抑制剂之间的协同活性 拓扑异构酶I和II。这是针对患者的I/II期临床试验 未接受治疗的晚期非小细胞肺癌患者 化疗。我们假设拓扑替康在 肿瘤患者治疗前拓扑异构酶水平较高 一、还假设拓扑替康治疗将导致 拓扑异构酶I水平降低和拓扑异构酶升高 II水平高于基线。目标是1)确定 有效率和有效时长，2)观察毒性 结合该方案，观察其在肿瘤活检中的效果。 样品，4)测定拓扑替康的药代动力学参数 血清水平与毒性和治疗反应及5) 观察拓扑异构酶I的活性和/或在体内的程度 拓扑替康对小鼠肝细胞拓扑异构酶I活性的体外抑制作用 转移性非小细胞肺癌与临床疗效相关 使用含有拓扑替康的化疗方案进行治疗。

This protocol utilizes a dose intense chemotherapy treatment regimen which takes advantage of the synergistic activity between inhibitors of topoisomerase I and II. This is a phase I/II clinical trial for patients with advanced non-small cell lung cancer who have not received prior chemotherapy. We hypothesize that topotecan will be most effective in patients whose tumors exhibit high pretreatment levels of topoisomerase I. It is also hypothesized that topotecan treatment will result in a diminution of topoisomerase I levels and an elevation of topoisomerase II levels above baseline. The objectives are to 1) determine the response rate and duration of response, 2) observe the toxicity associated with this regimen, 3) to observe the effect in tumor biopsy samples, 4) to determine topotecan pharmacokinetic parameters and to correlate serum levels with toxicity and response to treatment and 5) to observe whether the activity of topoisomerase I and/or the extent of in vitro inhibition of topoisomerase I activity by topotecan in primary and metastatic non-small cell lung cancer correlate with clinical response to treatment with a topotecan-containing chemotherapy regimen.