PHASE II MULTIPLE-DOSE SAFETY & EFFICACY STUDY OF A SELE

II 期多剂量安全性

• 批准号: 2540016
• 负责人: PATRICK M. LYNCH
• 金额: $ 152.54万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-30 至 1999-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2540016
• 关键词: biomarker; cancer prevention; chemoprevention; clinical research; colorectal neoplasms; drug administration rate /duration; drug screening /evaluation; family genetics; genetic carriers; histopathology; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer genetics; nonsteroidal antiinflammatory agent; oxidoreductase inhibitor; prostaglandin endoperoxide synthase

This is a randomized, double-blind placebo-controlled pharmacologic intervention trial in HNPCC patients and carriers (with or without prior clinical manifestations). The study arms are: 1) cyclooxygenase-2 (COX-2) inhibitor or NSAID at dose #1 p.o. BID, 2) cyclooxygenase-2 (COX-2) inhibitor or NSAID at dose #2 p.o. BID, and 3) placebo. There will be 18 patients randomized to each of the arms. The study drugs will be given for twelve months (365+/- 10 days). Assessment of endoscopic, histopathologic, and cellular endpoints will be conducted at baseline, three, and twelve months on study drug or placebo. Safety monitoring will occur via in- patient interviews with exams at months three and twelve; blood and UA's at months one, three, six, nine, and twelve; and via telephone interviews at monthly (at weeks two and four of month one) intervals. A post- administration telephone call to evaluate side effect resolution will occur at month 14, in those with side effects at termination. A parallel project involving approximately 20 subjects will be conducted at another NCI-designated site; NCI will coordinate the efforts and activities of both sites.

这是一项随机、双盲、安慰剂对照的药理学研究， HNPCC患者和携带者的干预试验（有或没有既往 临床表现）。研究组为：1）环氧合酶-2（考克斯-2） 抑制剂或NSAID，剂量#1 p.o. BID，2）环氧合酶-2（考克斯-2） 抑制剂或NSAID，剂量#2 p.o. BID和3）安慰剂。将有18 患者随机分配至每组。研究药物将用于 十二个月（365+/- 10天）。内镜、组织病理学、 将在基线、3和12时进行细胞终点 接受研究药物或安慰剂治疗的月数。安全监测将通过以下方式进行- 患者在第3个月和第12个月接受检查;血液和UA 在第一、三、六、九和十二个月;并通过电话采访 每月一次（第一个月的第二周和第四周）。一个后- 给药电话，以评估副作用解决情况， 发生在第14个月，在终止时有副作用的患者中。 并行 一个涉及约20个科目的项目将在另一个 NCI指定的研究中心; NCI将协调 两个网站。