PHASE II STUDY OF DOCETAXEL AND OXALIPLATIN ASSOCIATION AS I LINE THERAPY IN ADVANCED NON SMALL CELL LUNG CANCER (NSCLC) PATIENTS: SCHEDULE-DEPENDENT ACTIVITY AND MOLECULAR TARGETS EVALUATION - ND

Conditions: ON SMALL CELL LUNG CANCER (NSCLC)
MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB

Registration Number: EUCTR2007-001123-35-IT

Lead Sponsor: ISTITUTO DERMOPATICO IMMACOLATA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age  18 years; both M/F; histological diagnosis of Stage IIIB (not susceptible of CH and/or RT, meaning supraclavear and/or laterocervical node involvement, pleural effusion), Stage IV NSCLC; not previuosly treated with chemotherapy for advanced disease. no second malignancy, except adequately treated in situ carcinoma of the cervix or non melanomic skin cancer; ECOG performance status 0-2; life expectancy of at least 3 months; no previous thoracic radiotherapy; complete work-up at least 3 weeks or less before inclusion; WBC, Neutrophils, RBC, Hgb, Platelets within normal ranges ( WBC > 3000; Neut.> 2000; Hgb > 9 g/dl; PLT >100.000 ); liver and renal function assessed as normal ( AST< 2.5 UNL; ALT< 2.5 UNL; ALP< 5 UNL; Serum Creatinine Levels < 140 mol/l ); no life-threatning co-morbidities; regular follow-up feasible; 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

previous chemotherapy; symptomatic or not irradiated brain metastases; bone metastases as only disease evidence; pregnancy or breastfeeding status. Pre-menopausal patients must undergo contrapcetive therapies; serious and/or life-threatning co-morbidities: severe cardiac impairment, unstable angina, recent myocardial infarction, arrythmia, epilepsy, dementia, severe neurologic and/or psychiatric syndromes, ongoing infections, hypercalcemia, uncontrolled diabetes, severe pulmonary disease. second malignancy, except adequately treated in situ carcinoma of the cervix or non melanomic skin cancer; WBC, Neutrophils, RBC, Hgb, Platelets within no normal ranges (see above); liver and renal function assessed abnormal (see above);

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: response rate toxicity evaluation;Secondary Objective: progression free survival (TTP); overall survival; identification of factors conditioning response to treatment; response duration;Primary end point(s): response rate toxicity evaluation

Secondary Outcome Measures