Phase I Study of ZD6474 and Temozolomide in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Maximum tolerated dose of vandetanib and temozolomide
研究概览
简要总结
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib and temozolomide in treating patients with advanced solid tumors that cannot be removed by surgery.
详细描述
OBJECTIVES:
- To determine the maximum tolerated dose of concurrently administered vandetanib and temozolomide in patients with unresectable, advanced solid tumors.
- To describe the toxicity profile of this regimen in these patients.
- To describe the response rate in patients treated with this regimen.
- To describe the effects of therapy on angiogenesis-related translational endpoints.
OUTLINE: Patients receive escalating doses of oral vandetanib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and prior to each treatment course for correlative laboratory studies, including evaluation of plasma VEGF levels by ELISA, serum angiogenesis assay, and measurement of circulating endothelial cell populations (CD133, CD34, CD146). Frozen serum and plasma samples are also stored for future research studies.
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 of vandetanib and temozolomide
Adverse events profile
Toxicity profile
Response profile
Time until any treatment-related toxicity
Time until treatment-related grade 3+ toxicity
Time until hematologic nadirs
Time to progression
Time to treatment failure
Correlation of changes in VEGF levels, serum angiogenesis, and circulating endothelial cells with response and dose levels
次要结局
未报告次要终点