PILOT PHARMACOKINETIC STUDY OF DOSE ADJUSTMENT OF VINORELBINE IN PATIENTS WITH

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是1)评估化疗药物长春瑞滨在没有标准治疗或因肝功能受损需要修改标准治疗的癌症患者中的安全性和剂量耐受性。长春瑞滨是一种化疗药物，已被用于治疗多种癌症，包括乳腺癌、肺癌、食道癌和淋巴结癌。服用后，身体会将其清除。这在很大程度上是由肝脏完成的。在肝功能下降的患者中，长春瑞滨的消除速度较慢，这可能导致副作用的发生率增加。因此，对于有肝功能下降证据的患者，建议减少长春瑞滨的剂量。然而，所需的减少量只能估计。希望能够更准确地确定长春瑞滨的最佳剂量，以便更安全、更有效地给药。吲哚菁绿（一种染料）和利多卡因（一种麻醉剂）是用来评估肝脏工作状况的药物。本研究利用吲哚菁绿和利多卡因预测长春瑞滨的去除率并指导给药。

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.