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

Conditions: Chemonaive ERCC1-positive locally advanced or metastatic Non-Small Cell Lung Cancer patients
MedDRA version: 9.1Level: SOCClassification code 10038738

Registration Number: EUCTR2009-010656-10-IT

Lead Sponsor: FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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