Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.
Secondary
- Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
- Correlate pharmacodynamic effects of this drug with toxicity and response in these patients.
- Determine compliance and adherence to this regimen and correlate with PK parameters 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
Capecitabine
26 patients received the pre-defined starting dose of capecitabine of 3,000 mg orally daily given in two divided doses. Two thirds of the patients received either the same dose or a 500 mg lower dose compared to what would have been administered with a commonly used body surface area (BSA)-dosing schedule (2,000 mg/m2 with rounding down to nearest 500 mg multiple).
干预措施: capecitabine (Drug)
结局指标
主要结局
Response Rate
时间窗: Participants were followed to progression, evaluated every 12 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Adherence and Compliance to Oral Medication Using Electronic Monitoring(3-week cycles of treatment up to 16 cycles)
- Pharmacokinetics of Capecitabine and Metabolites as Assessed by Maximum Plasma Concentration(0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours)
- Pharmacokinetics of Capecitabine and Metabolites as Assessed by Area Under the Curve (AUC)(0.25, 0.5, 1, 2, 3, 4, 5, 6 and 8 hours)
- Time to Treatment Failure(3-week cycles of treatment up to 16 cycles)
- Clinical Benefit as Assessed by Lack of Progression for at Least 24 Weeks(3-week cycles of treatment up to 16 cycles)