NCT00277043已完成3 期
A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient HSR severity will be graded with an integer from 1 to 5 using the National Cancer Institute's Common Toxicity Criteria (CTC) for allergy/immunology. All Grade 3-4 HSRs will be reported through the FDA's MedWatch program
研究概览
简要总结
The purpose of this study are to determine whether a test dose program for taxanes will reduce the rate and/or severity of hypersensitivity reactions (HSR); and to determine whether a test dose program for taxanes will result in cost reduction due to decreased drug wastage.
详细描述
Patients will be randomized on to one of two arms:
- Test dose arm 1 mg paclitaxel or docetaxel test dose is prepared in 3 ml of normal saline and administered over two to five minutes IV push at least 30 minutes after prescribed IV and PO pre-medications. If no discernable adverse reaction ensues, the balance of the taxane dose is prepared and administered as per standard or specific chemotherapy protocol.
- Non test dose arm The full taxane dose is prepared and administered as per standard or specific chemotherapy protocol, at least 30 minutes after prescribed IV and PO pre-medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient must sign informed consent
- •Patient must be greater than 18 years of age
- •Patient must be receiving his/her first dose of either Taxol or Taxotere
- •Patient must have received routine premedications for hypersensitivity reactions
排除标准
- 未提供
研究组 & 干预措施
1 Test Dose
Experimental
干预措施: paclitaxel, docetaxel, taxane (Drug)
2) Non test dose arm
Active Comparator
干预措施: taxane (Drug)
结局指标
主要结局
Patient HSR severity will be graded with an integer from 1 to 5 using the National Cancer Institute's Common Toxicity Criteria (CTC) for allergy/immunology. All Grade 3-4 HSRs will be reported through the FDA's MedWatch program
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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