A THREE ARM PHASE II CHEMOPREVENTION TRIAL IN ADENOMATOU

在 ADENOMATOU 进行的三臂 II 期化学预防试验

• 批准号: 6156851
• 负责人: Frank A. Sinicrope
• 金额: $ 79.3万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6156851
• 关键词: adenomatous polyps; biomarker; cancer prevention; chemoprevention; clinical research; clinical trials; colorectal neoplasms; combination cancer therapy; difluoromethylornithine; human subject; human therapy evaluation; nonsteroidal antiinflammatory agent; placebos

Persons with familial adenomatous polyposis (FAP) have a nearly 100 percent lifetime risk of cancer, most often involving the upper or lower GI tract. Development of a cancer chemopreventive agent that could reduce this risk would offer a significant benefit. Nonsteroidal anti-inflammatory agents (NSAIDs) have shown efficacy in this disease by regressing prevalent colorectal adenomas. This trial seeks to determine the relative efficacy and tolerability of a promising agent combination (NSAID + difluoromethylornithine), versus an NSAID alone, versus placebo given over 6 months in 50 persons with FAP. The primary endpoint will evaluate the quantitative reduction in several parameters of colorectal adenomas following a six month period of administration. Other objectives include the evaluation of the treatments' efficacy against duodenal adenomas, and a panel of efficacy- and drug effect-biomarkers in duodenal and colorectal mucosa. Biomarker assessments are anticipated to improve mechanistic insights and iterative agent identification/development for this disease.

家族性腺瘤性息肉病(FAP)患者一生中患癌症的风险几乎为100%，最常见的是上消化道或下消化道。开发一种可以降低这种风险的癌症化学预防药物将提供显著的好处。非类固醇抗炎药(NSAIDs)通过逆转常见的结直肠腺瘤显示出对这种疾病的疗效。这项试验试图确定在50名FAP患者中，一种有希望的药物组合(NSAID+二氟甲基鸟氨酸)与单独使用NSAID的相对有效性和耐受性，以及服用6个月以上的安慰剂的情况。主要终点将评估在给药六个月后结直肠腺瘤的几个参数的定量减少。其他目标包括评估治疗十二指肠腺瘤的疗效，以及十二指肠和结直肠粘膜的一组疗效和药物效果生物标记物。生物标记物评估有望改善对这种疾病的机械性洞察和迭代试剂识别/开发。