Phase II study on the combined systemic and intrathecal chemotherapy with methotrexate, ifosfamide and liposomal cytarabine (DepoCyte®) in patients with HER-2/neu-negative breast cancer and leptomeningeal spread - MTXIFODepocyte

Charité-Universitätsmedizin Berlin0 个研究点目标入组 30 人开始时间: 2009年12月10日最近更新: 2012年11月12日

试验速览

暂无简介。

•HER-2/neu-negative breast cancer
•leptomeningeal spread
•Distance from the last administration of cytostatic therapy of at least 3 weeks, except for the unique application of intrathecal methotrexate 15 mg within one week is allowed before enrollment.
•ECOG performance score =2
•no active infection
•age =18 years
•adequate renal function (Creatinine-Clearance >50 ml/min)
•adequate bone marrow reserve (peripheral granulocytes >1500/µl and thrombocytes >80000/µl)
•bilirubine up to 3 mg/dl, GOT <3 times the upper limit of normal (if liver metastases <5 times the upper limit of normal )
•negative pregnancy test and adequate contraception
•written informed consent
•availability and compliance
•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

•breast cancer without leptomeningeal spread
•simultaneous participation in another clinical trial
•simultaneous or previous other malignant disease in the past 5 years
•treatment with salicylates, beta-lactam antibiotics or non-steroidal antirheumatic agents within one week before start of the MTX-containing treatment
•co-morbidities, appearing to make an intensive chemotherapy impossible
•large accumulation of extravascular fluid (e.g. pleural effusion, ascites)
•radio therapy of the skull or the whole cerebrospinal fluid space
•known intolerance to MTX, IFO, or DepoCyte®
•pregnant or breastfeeding women
•women of childbearing age without highly effective contraception (defined as Pearl-Index <1)

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