Phase I Radiosensitization Study of GW572016 With Biologic Correlates in Locoregionally Recurrent Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Inhibition of receptor and downstream signal transduction pathway activation in tumor tissue as assessed by IHC
研究概览
简要总结
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving lapatinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with radiation therapy in treating patients with locally recurrent or chemotherapy-refractory locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity of lapatinib ditosylate and radiotherapy in patients with locally recurrent breast cancer or chemotherapy-refractory, locally advanced or metastatic breast cancer.
- Determine the impact of this drug on inhibition of receptor and downstream signal transduction pathway activation in tumor tissue, in the context of inhibitor dose escalation with or without radiotherapy.
Secondary
- Determine, preliminarily, the efficacy of lapatinib ditosylate and radiotherapy in these patients.
- Correlate response in these patients with inhibition of downstream signaling.
- Assess gene expression changes in tumor biopsy samples from patients treated with lapatinib ditosylate alone or in combination with radiotherapy.
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 120 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
GW572016
干预措施: immunohistochemistry staining method (Other)
GW572016
干预措施: biopsy (Procedure)
GW572016
干预措施: lapatinib ditosylate (Drug)
GW572016
干预措施: TdT-mediated dUTP nick end labeling assay (Genetic)
GW572016
干预措施: gene expression analysis (Genetic)
GW572016
干预措施: microarray analysis (Genetic)
GW572016
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Inhibition of receptor and downstream signal transduction pathway activation in tumor tissue as assessed by IHC
时间窗: 4-5 years
Toxicity as assessed by NCI CTCAE v3.0
时间窗: 4-5 years
次要结局
- Gene expression(4-5 years)
- Efficacy(4-5 years)
- Correlation of response with inhibition of downstream signaling(4-5 years)