EUCTR2009-010656-10-IT进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
研究者
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