CLINICAL TRIAL: OXALIPLATIN IN COMBINATION WITH PACLITAXEL IN PATIENTS WITH CERV

临床试验：奥沙利铂联合紫杉醇治疗 CERV 患者

• 批准号: 7718422
• 负责人: SALLY E BLANK
• 金额: $ 0.14万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718422
• 关键词: Cisplatin; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; End Point; Funding; Grant; In complete remission; Incidence; Institution; Kidney; Malignant neoplasm of cervix uteri; Measurable; Measurable Disease; Non-Measurable; Outcome; Paclitaxel; Patients; Pelvis; Phase; Radiation therapy; Rate; Recovery; Recurrence; Research; Research Personnel; Resistance; Resources; Source; Toxic effect; United States National Institutes of Health; chemotherapy; cohort; improved; oxaliplatin; partial response; response; tumor

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 aim of this phase I-II study is to determine the response rates and toxicities and recovery for patients with locally recurrent or metastatic cervical cancer. The rationale of the study is that there has been no improvement in survival in patients with metastatic (outside the pelvis) disease with chemotherapy/radiotherapy. Cisplatin has been the most active agent but has shown no improvement in clinical outcome. Cisplatinum/paclitaxel improves the response rate but not survival. The investigators will now try oxaliplatin, which has been shown to be active in some cisplatinum-resistant tumors. Also, there is no significant renal toxicity with oxaliplatin, and there has been a high incidence of renal involvement in this cohort. Endpoints of the study are measurable and non-measurable disease; complete response, partial response, etc; toxicity and recovery.

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I-II期研究的目的是确定局部复发或转移性宫颈癌患者的应答率、毒性和恢复情况。这项研究的基本原理是，接受化疗/放射治疗的转移性(骨盆外)疾病患者的存活率没有改善。顺铂一直是最活跃的药物，但在临床结果方面没有任何改善。顺铂/紫杉醇可提高缓解率，但不能提高存活率。研究人员现在将尝试奥沙利铂，它已被证明对一些顺铂耐药肿瘤有效。此外，奥沙利铂没有明显的肾脏毒性，在这个队列中肾脏受累的发生率很高。研究的终点是可测量和不可测量的疾病；完全应答、部分应答等；毒性和恢复。