Determination of Carboplatin's Optimal Plasmatic Exposure

Institut Claudius Regaud16 个研究点分布在 1 个国家目标入组 400 人开始时间: 2005年5月最近更新: 2009年3月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Institut Claudius Regaud
入组人数: 400
试验地点: 16
主要终点: To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
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

•Carcinoma histologically proved and which must be treated by Carboplatin, excepted weekly administered Carboplatin treatments
•Age > 18 years
•Neutrophils > 1500/mm3, blood-platelets > 100000/mm3
•Patient with intravenous administration route for chemotherapy independent of the one used for blood samples ( for Investigators centers achieving pharmacokinetic examination)
•Well-informed written consent, signed by the patient

排除标准

•Carboplatin treatment's contra-indication
•Patient with clinically detectable cerebral metastasis
•Pregnant or nursing women
•Patient under guardianship or trusteeship
•Patient whose venous status don't permit a peripheral intravenous administration route's placing (for Investigators centers achieving pharmacokinetic examination)

结局指标

主要结局

To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.

次要结局

To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.

研究者

发起方

Institut Claudius Regaud

申办方类型

Other

研究点 (16)

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