Evaluation of Dihydropyrimidine Dehydrogenase (DPD) Activity in Surgically Resected Primary and Metastatic Colorectal Cancer After 48 hr Pretreatment With Eniluracil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Primary Goal to demonstrate that eniluracil at current clinical doses
研究概览
简要总结
RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor enzymes that break down chemotherapy drugs.
PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by surgery in treating patients who have primary or metastatic colorectal cancer.
详细描述
OBJECTIVES: I. Determine the enzymatic activity of dihydropyrimidine dehydrogenase (DPD) in peripheral blood mononuclear cells (PBMC), normal mucosa, or normal liver in patients with primary or metastatic colorectal cancer. II. Evaluate the ability of eniluracil to inactivate DPD in the tumor, PBMCs, and normal tissue in this patient population. III. Assess DPD recovery and uracil levels in PBMCs following surgical resection in these patients.
OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to colorectal tumor (primary vs metastatic). Patients are randomized into one of two treatment arms. Arm I: Patients receive oral eniluracil twice daily on days -2 and -1 followed by surgical resection and tissue harvest on day 0. Arm II: Patients receive an oral placebo as in arm I followed by surgical resection and tissue harvest on day 0. Patients are followed weekly for 1 month.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 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
Oral eniluracil 20 mg twice daily
20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection
干预措施: eniluracil (Drug)
Oral eniluracil 20 mg twice daily
20 mg of eniluracil given twice daily for duration of the study. This subject may have surgery IF tumor is amenable to resection
干预措施: conventional colon surgery (Procedure)
Placebo
20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection
干预措施: eniluracil (Drug)
Placebo
20 mg placebo that will be given for the duration of the study. This subject may have surgery IF tumor is amenable to resection
干预措施: conventional colon surgery (Procedure)
结局指标
主要结局
Primary Goal to demonstrate that eniluracil at current clinical doses
时间窗: Pre-operative and up to 30 days after first dose
To see if at standard clinical doses are capable of inhibiting DPD in Primary and metastatic colorectal cancer in vivo. Since one of the mechanisms of 5-FU(Fluorouracil) tumor resistance is overexpression of DPD,effective inactivation DPD in tumors by eniluracil in this study will be supportive of the use of eniluracil to overcome this type of 5-FU(Fluorouracil) resistance
次要结局
- Evaluate DPD recovery and uracil levels(pre-operative and up to 30 post first dose)
研究者
Marty Heslin
Chief of Surgical Oncology
University of Alabama at Birmingham