Multicenter Phase II study of Sequential Chemotherapy with Cisplatin/Gemcitabine Followed by Docetaxel in Elderly Advanced Non-Small-Cell Lung Cancer (NSCLC) patients - ELDERLY-NEXT

• Conditions: elderly advanced NSCLC patients; MedDRA version: 9.1Level: LLTClassification code 10001160; MedDRA version: 9.1Level: LLTClassification code 10001162; MedDRA version: 9.1Level: LLTClassification code 10025031

• Registration Number: EUCTR2008-005294-35-IT
• Lead Sponsor: AZIENDA USL 6 LIVORNO ZONA LIVORNESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-22
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Histological or cytological diagnosis of non-small-cell lung cancer
-Measurable disease according to RECIST criteria (see appendix)
-Stage IIIB (ciyologicallly positive pleural effusion or metastatic supraclavicular lymphonodes)
-Stage IV
-Age > 70 years
-ECOG performance status 0, 1.
-Life expectancy longer than 3 months
-Adequate bone marrow reserve (leukocyte count > 4.0 x 109/L, platelet count > 100 x 109/L)
-Adequate hepatic function (bilirubin level <1.5 mg/dL) and renal function (creatinine level < 1.5 mg/dL).
-Written informed consence
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

-Patient defined ?frail? according to the criteria reported in appendix
-Second primary malignancy
-Previuos chemotherapy for the metastatic disease
-Symptomatic brain metastases
-The presence of active infections
-Recent myocardial infarction
-Unstable angina

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The evaluation of patient rate no progressed at 4th month (end of treatment);Secondary Objective: -The evaluation of response rate.<br>-The evaluation of the conversion rate from SD to PR followed by docetaxel.<br>-The evaluation of time to progression of sequential regimen<br>- The evaluation of overall survival;Primary end point(s): progression rate