PILOT PHARMACOKINETIC STUDY OF DOSE ADJUSTMENT OF VINORELBINE IN PATIENTS WITH

点击翻译按钮获取中文摘要

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. The purpose of this research study is 1) to evaluate the safety and dose tolerance of the chemotherapy drug, vinorelbine in patients who have cancer for which there is no standard therapy or for which standard therapy would need to be modified due to impaired liver function. Vinorelbine is a chemotherapeutic agent that has been used against a variety of cancers, including cancers of the breast, lung, esophagus, and lymph node. After it is administered, the body eliminates it. To a large extent this is done by the liver. In patients with decreased function of the liver, vinorelbine is eliminated more slowly, which could lead to an increased incidence of side effects. As a result, decreased doses of vinorelbine are recommended in patients that have evidence of decreased liver function. The amount of decrease necessary, however, can only be estimated. It would be desirable to be able to determine more accurately the best dose of vinorelbine to allow safer, and potentially more effective administration of the drug. Indocyanine green (a dye) and lidocaine (an anesthetic) are drugs that have been used to estimate how well the liver is working. This study utilizes indocyanine green and lidocaine to predict the rate of removal of vinorelbine and to guide the dosing.