A Phase I Study Of Weekly Taxotere (Docetaxel) And Gleevec (STI571, Imatinib Mesylate, CGP 57148B) In Locally Advanced Or Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 2.1.1 To determine the safety profile, maximum tolerated dose, and recommended dose for subsequent phase II studies of a combination regimen of daily STI571 with weekly docetaxel on days 1, 8, and 15 in a 28-day cycle.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with imatinib mesylate in treating patients with locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety profile, maximum tolerated dose, and recommended phase II dose of docetaxel when administered with imatinib mesylate in patients with locally advanced or metastatic breast cancer.
Secondary
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine the potential effects of this regimen on CYP3A4 activity and docetaxel metabolism in these patients.
- Correlate docetaxel and imatinib mesylate exposure (utilizing total and unbound docetaxel and imatinib mesylate plasma concentrations) with drug response (e.g., pharmacodynamic effects, drug toxicity, and response) in these patients.
- Determine response rate, duration of response, and time to treatment failure in patients treated with this regimen.
- Correlate proteomic profile changes in serum with tumor burden and response in patients treated with this regimen.
- Correlate pharmacokinetic parameters, tissue expression of specific receptor tyrosine kinases (e.g., c-Kit, platelet-derived growth factor receptor [PDGFR], and phosphorylated PDGFR) in paraffin blocks, and pharmacodynamic assays with antitumor activity of this regimen in these patients.
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
Imatinib mesylate and docetaxel
Imatinib mesylate (400-600 mg, oral, once daily) and docetaxel (15-30 mg/m2, IV, weekly on days 1, 8, and 15) each 28 day cycle
干预措施: docetaxel (Drug)
Imatinib mesylate and docetaxel
Imatinib mesylate (400-600 mg, oral, once daily) and docetaxel (15-30 mg/m2, IV, weekly on days 1, 8, and 15) each 28 day cycle
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
2.1.1 To determine the safety profile, maximum tolerated dose, and recommended dose for subsequent phase II studies of a combination regimen of daily STI571 with weekly docetaxel on days 1, 8, and 15 in a 28-day cycle.
时间窗: 4 weeks
次要结局
未报告次要终点