NCT00081237已完成1 期
A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer
European Organisation for Research and Treatment of Cancer - EORTC4 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2004年2月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0
研究概览
简要总结
RATIONALE: OSI-7904L may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining OSI-7904L with oxaliplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of OSI-7904L and oxaliplatin in treating patients with refractory or recurrent advanced colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity of OSI-7904L and oxaliplatin in patients with refractory or recurrent advanced colorectal cancer.
- Determine the maximum tolerated dose of this regimen in these patients.
- Determine a safe dose for this regimen in these patients.
Secondary
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine the safety profile of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 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
结局指标
主要结局
Maximum tolerated dose and recommended dose for future trials as measured by CTC v3.0
次要结局
- Safety profile as measured by CTC v3.0
- Response as measured by RECIST every 6 weeks (2 courses)
- Pharmacodynamics as measured by drug concentration in the blood during course 1
- Time to progression as measured by Kaplan Meier and RECIST every 6 weeks during treatment and then every 8 weeks
研究者
研究点 (4)
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