elderly advanced NSCLC patients MedDRA version: 9.1 Level: LLT Classification code 10001160 MedDRA version: 9.1 Level: LLT Classification code 10001162 MedDRA version: 9.1 Level: LLT Classification code 10025031 MedDRA version: 9.1 Level: LLT Classification code 10001160
Conditions
Interventions
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical Form: Concentrate fo
Sponsors
AZIENDA USL 6 LIVORNO ZONA LIVORNESE
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The evaluation of patient rate no progressed at 4th month (end of treatment);Secondary Objective: -The evaluation of response rate. -The evaluation of the conversion rate from SD to PR followed by docetaxel. -The evaluation of time to progression of sequential regimen - The evaluation of overall survival;Primary end point(s): progression rate | — |
Countries
Italy
Outcome results
None listed