NCT00112892已完成1 期
A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with selenium may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the optimal loading and maintenance doses of selenium necessary to achieve selenium concentrations exceeding 15 μM when administered with irinotecan in patients with advanced solid tumors.
Secondary
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the toxic effects of this regimen in these patients.
- Determine any observed tumor response to this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid CancerHead and Neck CancerNCT00100828Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins6
已完成
2 期
Irinotecan and Cetuximab in Treating Patients With Metastatic Breast CancerBreast CancerNCT00275041Alliance for Clinical Trials in Oncology21
已完成
1 期
Irinotecan in Treating Asian Patients With Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00731276National Cancer Centre, Singapore18
已完成
1 期
Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid TumorsBrain and Central Nervous System TumorsCognitive/Functional EffectsLong-term Effects Secondary to Cancer Therapy in AdultsLong-term Effects Secondary to Cancer Therapy in ChildrenPoor Performance StatusUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol SpecificNCT00389584University of California, Davis30
已完成
1 期
Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving AnticonvulsantsUnspecified Childhood Solid Tumor, Protocol SpecificNCT00008424Children's Oncology Group7