Preclinical and clinical evaluation of the activity of Docetaxel and Gemcitabine in chemonaive ERCC1-positive locally advanced or metastatic Non-Small Cell Lung Cancer patients (PLP-09) - PLP-09

FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE0 个研究点开始时间: 2009年3月9日最近更新: 2014年1月27日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE

暂无简介。

•- Histologically/cytologically confirmed diagnosis of stage IIIB/IV NSCLC - ERCC1 positive NSCLC (IHC and RT-PCR whenever possible) - No prior chemotherapy for advanced disease - At least 1 measurable (target) lesion according to RECIST criteria. - Age > 18 <75 years - PS ECOG 0-2 - Life expectancy >3months - Neutrophils>1.5x10e9/L, Platelets >100x10e9/L, Hb>9 g/dl, AST e ALT <2.5xULN (if no liver mets), total serum bilirubin <1.5xULN, creatinine <1.5xULN - Written informed consent
•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

•- Prior chemotehrapy or radiotherapy for advanced disease - Adjuvant therapy with gemcitabina and or docetaxel if administered in the last year - Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investiagator would place the subject at undue risk or interfere with the results of the study - Previous concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin or in situ cervical carcinoma within 5 years - Symptomatic brain metastasis or leptomeningeal disease requiring therapy - Pregnancy or lactation or unwillingness to use adeguate method of birth control

发起方