INTRAPLEURAL DOCETAXEL IN MALIGNANT PLEURAL EFFUSION

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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.