Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 34
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.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors.
详细描述
OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects, BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these patients.
OUTLINE: Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician.
PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 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 —（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
paclitaxel
Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician.
干预措施: paclitaxel (Drug)