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

临床试验：长春瑞滨剂量调整的试点药代动力学研究

• 批准号: 7716639
• 负责人: Stephen I Shibata
• 金额: $ 5.17万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716639
• 关键词: Adverse effects; Anesthetics; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Dyes; Esophagus; Excision; Funding; Grant; Incidence; Indocyanine Green; Institution; Lead; Lidocaine; Liver; Lung; Malignant Neoplasms; Patients; Pharmaceutical Preparations; Purpose; Rate; Research; Research Personnel; Resources; Safety; Source; Standards of Weights and Measures; United States National Institutes of Health; Vinorelbine; Work; chemotherapeutic agent; chemotherapy; liver function; malignant breast neoplasm; research study

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是1）评价化疗药物长春瑞滨在无标准治疗或因肝功能受损而需要调整标准治疗的癌症患者中的安全性和剂量耐受性。 长春瑞滨是一种化学治疗剂，已用于治疗多种癌症，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，长春瑞滨的消除更慢，这可能导致副作用的发生率增加。因此，在有证据表明肝功能下降的患者中，建议减少长春瑞滨的剂量。然而，所需减少的数额只能估计。希望能够更准确地确定长春瑞滨的最佳剂量，以允许更安全且可能更有效地施用药物。吲哚菁绿色（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色和利多卡因预测长春瑞滨的清除率并指导给药。