CLINICAL TRIAL: PILOT PHARMACOKINETIC STUDY OF DOSE ADJUSTMENT OF VINORELBINE IN

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。 这项研究的目的是1)评估化疗药物长春瑞滨在没有标准治疗方法的癌症患者中的安全性和剂量耐受性，或者由于肝功能受损而需要修改标准治疗方法的癌症患者。 长春瑞滨是一种化疗药物，已用于治疗各种癌症，包括乳腺癌、肺癌、食道癌和淋巴结癌。在给药后，身体就会消除它。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，这可能会导致副作用发生率增加。因此，建议在有肝功能下降证据的患者中减少长春瑞滨的剂量。然而，所需的减少量只能估计。人们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。吲哚青绿(一种染料)和利多卡因(一种麻醉剂)是用来评估肝脏工作情况的药物。本研究利用吲哚青绿和利多卡因来预测长春瑞滨的清除率并指导给药。

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 lymphnode. 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.