A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Detection of Any Adenoma at the End of the Study
研究概览
简要总结
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer
详细描述
PRIMARY OBJECTIVES:
I. Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.
II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients.
III. Compare the rate of side effects in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm II (placebo)
Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
干预措施: placebo (Other)
Arm II (placebo)
Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
干预措施: laboratory biomarker analysis (Other)
Arm I (eflornithine and sulindac)
Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
干预措施: eflornithine (Drug)
Arm I (eflornithine and sulindac)
Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
干预措施: sulindac (Drug)
Arm I (eflornithine and sulindac)
Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Detection of Any Adenoma at the End of the Study
时间窗: Up to 36 months
Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.
次要结局
- Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment(Up to 36 months)
- Biomarker in Adenoma: CEA(At the end of the study)
- Biomarker in Adenoma: Sialyl-TN (B72.3)(At the end of the study)
- Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment(Up to 36 months)
- Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment(Up 36 months)
- Baseline Putrescine by ODC Genotype(Baseline)
- At the End of the Study - Putrescine Response by ODC Genotype(At the end of the study)
- Biomarker in Adenoma: Bcl-2(At the end of the study, up to 3 years)
- Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment(Up 36 months)
- Baseline Spermine by ODC Genotype(Baseline)
- At the End of the Study - Spermidine Response by ODC Genotype(At the end of the study)
- Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group(Up to 36 months)
- Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment(Up to 36 months)
- Baseline Spermidine by ODC Genotype(Baseline)
- Biomarker in Adenoma: Apoptosis(At the end of the study)
- Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment(Up to 36 months)
- Adverse Events With a Grade of 3 and Above(Up to 36 months)
- At the End of the Study - Spermine Response by ODC Genotype(At the end of the study)
- Biomarker in Adenoma - Ki-67(At the end of the study)
- Biomarker in Adenoma - p53(At the end of the study)