A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 12
- 主要终点
- Confirmed complete and partial response rate to R115777
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.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or advanced colorectal cancer.
详细描述
OBJECTIVES: I. Determine the response rate to R115777 in patients with disseminated colorectal cancer who have been previously treated for advanced disease. II. Assess the time to treatment failure and survival of these patients with this treatment regimen. III. Determine the frequency and severity of toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
R115777
R115777, 300mg PO BID on Days 1-21. 1 cycle=28 days.
干预措施: R115777 (Drug)
结局指标
主要结局
Confirmed complete and partial response rate to R115777
时间窗: Once every 8 weeks until progression
Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.
次要结局
- Time to treatment failure and survival(Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration)
- Frequency & severity of toxicities(Weekly for 8 weeks and then once every 4 weeks until progression)