Phase III Colon Cancer Prevention Trial

描述(由申请人提供)：我们工作的长期目标是开发安全有效的药物来预防结肠癌，结肠癌是美国第四大常见癌症，2000年有超过58,000人死于结肠癌。 我们在此应用程序中的具体目标是： 1.进行一项随机、双盲、安慰剂对照的III期临床化学预防试验，研究DFMO和舒林酸联合应用以降低新的腺瘤性息肉形成率。 2.联合用药对扁平粘膜中多胺和前列腺素含量的影响与腺瘤形成率的关系。 3.确定在干预过程中随机接受联合治疗的患者的副作用发生率。 这项研究的主要目标是在不产生比安慰剂组更大的毒性的情况下降低腺瘤性结肠息肉的复发率。我们工作的总体目标是开发可用于实践环境并补充当前监测努力的安全的化学预防制剂组合。

DESCRIPTION (provided by the applicant): The long-range objective of our work is to develop safe and effective drugs to prevent colon cancer, which is the fourth most common incident cancer in America with over 58,000 people dying of the disease in the year 2000. Our specific aims in this application are: 1.To conduct a randomized, double-blind placebo-controlled phase III clinical chemoprevention trial of the combination of DFMO plus sulindac to decrease the rate of new adenomatous polyp formation. 2. To correlate the effects of the combination on polyamine and prostaglandin contents in the flat mucosa to the rate of adenoma formation. 3. To determine the rate of side effects in patients randomized to the combination therapy over the course of the intervention. The major objectives of this investigation are to reduce the recurrence rate of adenomatous colonic polyps without producing toxicity greater than that seen in the placebo group. The overall goal of our work is to develop safe combinations of chemoprevention agents that can be used in the practice setting and complement current surveillance efforts.