A MULTICENTER PHASE II STUDY TO EVALUATE ACTIVITY AND TOLERABILITY OF CISPLATIN (CDDP) AND FOTEMUSTINE (FTM) COMBINATION IN NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS WITH BRAIN METASTASES. - PHASE II in NSCLC PATIENTS WITH BRAIN METASTASES

GOIM GRUPPO ONCOLOGICO MERIDIONALE0 个研究点开始时间: 2007年7月6日最近更新: 2012年3月19日

适应症

试验速览

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•INCLUSION CRITERIA: 1 Histologically or cytologically confirmed diagnosis of adnaced NSCLC; 2.Brain metastases, radiologically measurable with TC or MNR, clinically asymptomatic and not amenable to definitive locoregional treatment 3 No prior chemotherapy 4 Males or females aged between 18 and 70 years; 5 ECOG Performance Status 0 or 1 6 Adequate laboratory requirements at entry - Blood cell counts: Absolute neutrophils > 2.0 . 109/L; Platelets > 100 . 109/L; Hemoglobin > 10 g/dl Renal function: Serum creatinine < 1.25 upper normal limits (UNL). Hepatic functions: ASAT and ALAT < 1.5 x UNL; Alkaline phosphatase < 5 x UNL (unless accompanied by extensive bone metastases) 7 Life expectancy of 3 months 8 Obtained signed informed consent prior to start protocol specific requirements;
•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

•EXCLUSION CRITERIA: 1 History of prior malignancies, except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years; 2 Prior brain radiotherapy 3 Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia; 4 Significant neurological or psychiatric disorders such as dementia that would prohibit them to understanding or rendering informed consent or from fully complying with treatment and follow-up; 5 Active infection requiring iv antibiotics; 6 Active ulcer, unstable diabetes mellitus or other contra-indication to corticotherapy; 7 Current peripheral neuropathy NCI grade > 2; 8 Participation in clinical trials with other experimental agents within 30 days of study entry;

发起方

GOIM GRUPPO ONCOLOGICO MERIDIONALE