PHASE II MULTICENTRIC STUDY OF SEQUENTIAL CHEMOTHERAPY WITH GEMCITABINE FOLLOWED FROM DOCETAXEL IN ELDERLY PATIENTS WITH NOT SMALL CELLS LUNG CANCER NSCLC ADVANCED - POLTO-Elderly04

• Conditions: SEQUENTIAL CHEMOTHERAPY IMPROVED THE ACTYVITY OF DOCETAXEL IN ELDERLY PATIENTS WITH NSCLC ADVANCED; MedDRA version: 6.1Level: PTClassification code 10029522

• Registration Number: EUCTR2005-001260-31-IT
• Lead Sponsor: AZIENDA USL 6 LIVORNO ZONA LIVORNESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

pulmonary histologic or cytological Diagnosis of NSLC measurable Disease second criteria RECIST Stage IIIB for cytologically positive pleuric deposit or sopraclavearic metastases Stage IV Age 70 years ECOG performance status 0 - 2 Expected life 3 months Adapted medullary functionality leucociti 4,0 x109/L, neutrophil 2,0 x 109/L, 100 plt x 109/L, emoglobina 10 g/dL Adapted renal hepatic functionality and bilirubinemia 1,2 mg/dL, transaminases 2,5 x VN, creatininemia 1,5 mg/dL informed Consent written
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

Diagnosi the brought back criteria inel protocol of other malignant neoplasie in last the 5 years except the carcinoma in situ of the cervix uterina and the basalioma or ca. to spinocellulare cutaneous adequately deals Previous chemotherapy to you for the metastatic disease Radioterapy on the neoplastic lesions cerebral Metastase sintomatic scompensate metabolic Diseases or infections in action cardiac Aritmye or ischemic cardiopathy not controlled impossibility to execute an adequate one follow-up

Study & Design

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