ADVANCED NON SMALL CELL LUNG CANCER (NSCLC) ELDERLY OR PS 2 PATIENTS MedDRA version: 6.1 Level: PT Classification code 10061873
Conditions
Interventions
Trade Name: NEXAVAR
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAY 43-9006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Trade Name: GEMZ
Sponsors
SECONDA UNIVERSITA' DEGLI STUDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed written informed consents Male or female > 70 years of age with ECOG PS 0-2 or ugual 3 months Neutrophils > ugual 1.5 x 109/L, platelets > ugual 100 x 109/L, and hemoglobin > ugual 9 g/dL Bilirubin level either normal or =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Brain metastases Previous chemotherapy Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy Hystory of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiering anti-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension. Patients with evidence or history of bleeding diathesis History of HIV infection or chronic hepatitis B or C Patients undergoing renal dialysis Acute or sub acute intestinal occlusion or history of inflammatory bowel disease Known grade 3 or 4 allergic reaction to any of the components of the treatment. Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent Women who are pregnant or breastfeeding Acute or sub acute intestinal occlusion Clinically relevant peripheral neuropathy Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for  5 years will be allowed to enter the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the 1-year survival rate in patients;Secondary Objective: To determine activity (response rate and disease control rate) of each treatment arm, toxicity and overall survival time;Primary end point(s): the primary endpoint of the study is objective response evaluation | — |
Countries
Italy
Outcome results
None listed