EVALUATION OF ACETYL -L-CARNITINE (ST 200) TO REDUCE INTENSITY OF TAXANES- OR PLATINUM-INDUCED SENSORY NEUROPATHY

Sigma-Tau i.f.r. S.p.A.0 个研究点目标入组 172 人开始时间: 2006年2月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Male and female age >/= 18 years;
•- Written informed consent;
•- Karnofsky > 60;
•- Life expectancy >/= 6 months;
•- Adequate organ functions defined as follows:
•- absolute neutrophil count >/= 1.0 *10^9 L
•- platelet count >/= 75.0 *10^9 L
•- serum creatinine level < 3 x UNL
•- alkaline phosphatase - taxanes- or platinum-induced sensory peripheral neuropathy grade 2 or 3, according to the sensory item of NCI-CTC version 3.0, at least 1 month after neurotoxic (taxanes or platinum-based) chemotherapy for cancer treatment discontinuation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Pre-existing neuropathies of different origin than those considered in this trial;
•- diabetes mellitus, insulin-dependent;
•- symptomatic brain metastases;
•- leptomeningeal involvement;
•- significant infective illness or active inflamed focus;
•- concomitant therapy with other neuroprotective agents (for details, see section 5.5 of the protocol);
•- any previous use of neuro-protectant drugs (such as sodium thiosulphate, glutathione, amifostine, gabapentin, lamotrigine, glutamic acid, ACTH analogues, neuronal growth factors, Vitamin E) if performed from the last chemotherapy administration, onwards;
•- any neurotoxic chemotherapy since one month prior to baseline;
•- predictable lack of patient’s co-operation;
•- pregnancy, nursing, or women of childbearing potential not using an effective method of birth control;
•- concomitant use of both platinum and taxane in the same line chemotherapy.

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