Maintenance treatment with Lanreotide in Patients with small cell lung cancer (LD/ED) expressing SST receptors, responsive to a first line standard chemotherapy/radiotherapy

A.O. UNIVERSITARIA INTEGRATA DI VERONA0 个研究点目标入组 134 人开始时间: 2011年12月16日最近更新: 2012年10月22日

适应症

试验速览

暂无简介。

•1.Age > 18 and < 75 2.Histological or cytological proven diagnosis of small-cell lung cancer (SCLC) LD and ED 3.Complete response or partial response after a first line standard chemotherapy/radiotherapy completed no more than 45 days before enrollment 4.SST receptors expression (as detected by Octreoscan uptake at diagnosis) 5.Performance Status (ECOG) 0-2 6.Life expectancy greater than 3 months 7.Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 14 days prior to the start of the study treatment (leucocyte count >3.000/µl, neutrophils >1.500/µl, platelet count >100.000/µl, total bilirubin <1.5 times the upper limit of normal (ULN), AST(SGOT) and ALT(SGPT) <2.5xULN, serum creatinine <1.25xULN (or >1.25xULN and <1.5xULN with creatinine clearance >60ml/min) 8.Negative pregnancy test (only for fertile women who must use effective contraception) 9.Patients must be accessible for treatment and follow up. 10.Patients must be able to understand and sign written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•1.Stable disease (SD) or progression (PD) after a first-line standard treatment (CT / RT) 2.Time > 45 days after the first line standard therapy 3.Clinically significant cardiovascular disease e.g. cerebrovascular accidents (=6 months), myocardial infarction (=6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication 4.Intercurrent and not controlled acute infectious disease 5.Psychological or social conditions which might affect study compliance 6.Severe Parkinson disease 7.Unstable neurologic function 8.Known history of atrophic gastritis 9.Known history of cholelithiasis 10.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized cancers (eg. Non melanoma skin cancer, cervical ) effectively treated 11. Patients with known allergy to any of the components of the study medication 12.Pregnancy or lactation 13.Treatment with any investigational drug within 30 days prior to enrolment 14.Prior treatment with somatostatin analoques.

发起方

A.O. UNIVERSITARIA INTEGRATA DI VERONA