A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of different schedules of irinotecan in combination with capecitabine as first-line therapy, in terms of objective response rate, in patients with advanced or metastatic colorectal cancer.
- Compare the time to treatment failure, time to progression, and overall survival of patients treated with these regimens.
- Compare the safety profile, in terms of toxicity, of these regimens in these patients.
- Determine the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of appetite, malaise, and fever of unknown origin (yes vs no); weight loss during the past 6 months (more than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6 months or less). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral capecitabine twice daily on days 1-14 and 22-35.
- Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral capecitabine as in arm I.
Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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 A
Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
干预措施: Irinotecan 70 mg/m2 (Drug)
Arm B
Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
干预措施: Irinotecan 240 mg/m2 (Drug)