CLINICAL TRIAL: A PHASE II TRIAL OF CAPECITABINE RAPIDLY DISINTEGRATING TABLETS

临床试验：卡培他滨快速崩解片的 II 期试验

• 批准号: 8356747
• 负责人: SUSAN M. BLANEY
• 金额: $ 3.48万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356747
• 关键词: Adverse event; Brain Stem Glioma; Child; Childhood; Clinical Research; Clinical Trials; Deglutition; Diffuse; Dose; Film; Flavoring; Funding; Grant; Interruption; National Center for Research Resources; Newly Diagnosed; Oral; Patients; Phase; Phase II Clinical Trials; Principal Investigator; Radiation; Radiation therapy; Research; Research Infrastructure; Resources; Rest; Source; Tablets; United States National Institutes of Health; Water; base; capecitabine; cost

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. This is a phase II protocol for children with newly diagnosed, diffuse intrinsic brain stem gliomas. Capecitabine RDT dosing during the radiation phase will be 650 mg/m2 administered twice daily and is based on the pediatric MTD of capecitabine with concomitant RT from the phase I pediatric trial. There should be no interruptions in capecitabine administration in the absence of unacceptable adverse event. Oral capecitabine RDT will continue for a total of nine weeks, followed by a two-week break. Post-RT therapy will begin after the two week break. Post radiation therapy, patients will receive twice daily oral capecitabine for 3 courses. During each course, capecitabine will be administered for 14 consecutive days followed by a 7-day rest period. Capecitabine will be provided as a flavored, film coated, rapidly disintegrating tablet that may be swallowed intact or dispersed in water for patients unable to swallow tablets.

该子项目是利用资源的众多研究子项目之一 由 NIH/NCRR 资助的中心拨款提供。子项目的主要支持 并且子项目的主要研究者可能是由其他来源提供的， 包括其他 NIH 来源。 子项目可能列出的总成本 代表子项目使用的中心基础设施的估计数量， NCRR 赠款不直接向子项目或子项目工作人员提供资金。 这是针对新诊断的弥漫性内源性脑干胶质瘤儿童的 II 期方案。 放射阶段卡培他滨 RDT 剂量为 650 mg/m2，每日两次，基于 I 期儿科试验中卡培他滨联合 RT 的儿科 MTD。在没有不可接受的不良事件的情况下，不应中断卡培他滨的给药。口服卡培他滨 RDT 将持续总共九周，然后休息两周。 RT 后治疗将在两周休息后开始。放射治疗后，患者将每天两次口服卡培他滨，持续 3 个疗程。在每个疗程中，卡培他滨将连续服用 14 天，然后休息 7 天。 卡培他滨将以调味、薄膜包衣、快速崩解片剂的形式提供，对于无法吞咽片剂的患者可以完整吞咽或分散在水中。