NCT00225056终止2 期
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Oncology Specialties, Alabama2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2003年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Overall clinical benefit rate
研究概览
简要总结
In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must have metastatic breast cancer
- •must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
- •must have measurable or evaluable disease
- •ECOG of 0-1
- •patients may have received 0,
- •or 2 prior treatments for metastatic breast cancer
- •must have adequate organ function
- •must be at least 19 years of age
- •peripheral neuropathy less than or equal to grade 1
- •must have voluntarily signed informed consent
- •patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled
排除标准
- •patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
- •patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
- •known uncontrolled existing coagulopathy
- •patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
- •use of other investigational agents in the last 28 days
- •pregnant or lactating women
- •patients who are known HIV positive
- •patients with life expectancy of less than 3 months
- •sexually active patients unwilling to practice reliable contraception during the study
结局指标
主要结局
Overall clinical benefit rate
次要结局
- safety and tolerability
- evaluate QOL
- determine progression free survival
- determine time to response and overall survival
研究者
研究点 (2)
Loading locations...
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