INTRAPLEURAL DOCETAXEL IN MALIGNANT PLEURAL EFFUSION

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 恶性胸腔积液(MPE)是癌症患者治疗中常见且具有挑战性的并发症，严重影响晚期疾病患者短暂生命的质量。MPE患者预后较差，目前治疗的平均生存期仅为3~6个月。需要研究和治疗MPE的新方法，可能依赖于新的化疗药物、替代给药方法以及更深入地分析与治疗相关的效果。这项I期试验的主要目标是评估通过胸腔内导管给MPE患者使用抗微管药物多西紫杉醇的安全性。将收集毒性数据、药代动力学数据、MPE治疗反应、MPE复发、总存活率，以及与使用多西他赛相关的胸液和外周血液的细胞因子和核因子-kB分析。在文献综述的基础上，涉及其他化疗药物治疗MPE的研究，这项试验旨在评估不同药物的安全性，希望改善这种进展性和疑难问题患者的临床护理。该试验将招募8-24名患者参加剂量递增研究，并监测剂量限制毒性，以努力确定最大耐受剂量。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Malignant pleural effusions (MPE) present a common and challenging complication in the treatment of cancer patients and can severely affect the quality of the remaining short life span of patients with terminal disease. The prognosis of patients with MPE is poor, with the average survival time in the face of current treatment being only 3-6 months. New approaches for studying and treating MPE are needed, and may rely on new chemotherapy drugs, alternate methods of drug delivery, and more in-depth analysis of treatment-related effects. The primary objective of this phase I trial is to assess the safety of the antimicrotubule agent, docetaxel, when administered via an intrapleural catheter to patients with MPE. Toxicity data, pharmcokinetic data, MPE response to treatment, MPE recurrence, overall survival, and cytokine and NF-kB analysis of pleural fluid and peripheral blood associated with the administration of the docetaxel will be gathered. Based on a literature review of studies involving other chemotherapy drugs for treatment of MPE, this trial is designed to evaluate the safety of a different agent in hopes of improving the clinical care of patients with this progressive and difficult problem. The trial will enroll 8-24 patients in a dose-escalating study and monitor for dose limiting toxicities in an effort to determine the maximum tolerated dose.