Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.
详细描述
OBJECTIVES:
- Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or third-line chemotherapy.
- Evaluate the toxic effects of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
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
- Female
- 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
To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
时间窗: 28 weeks
次要结局
- To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil(28 weeks)