A Study of Cetuximab and Bevacizumab in Combination With Paclitaxel and Carboplatin in Stage IIIb/IV NSCLC

Exclusion Criteria

• •The patient has known Central Nervous System metastases. A head computed tomography (CT) is required within 4 weeks prior to the first dose of study medication (magnetic resonance imagines \[MRIs\] are also acceptable).
• •The patient has received prior cetuximab therapy.
• •The patient has received prior bevacizumab therapy.
• •The patient has received prior systemic chemotherapy or radiation therapy at any time for lung cancer.
• •Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with adequately treated cancers of other histologies who have been disease-free for more than 3 years prior to the first treatment dose are eligible.
• •Concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy.
• •The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •The patient has a history of thrombotic or hemorrhagic disorders.
• •The patient has uncontrolled hypertension (\>150/100 mmHg) on a standard regimen of anti-hypertensive therapy.
• •The patient is receiving chronic daily treatment with aspirin (\>325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function.
• •The patient is receiving treatment with dipyridamole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®).
• •The patient is receiving anti-coagulation therapy. Prophylactic anti-coagulation of venous access devices is allowed. Caution should be taken on treating patients with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding.
• •Patients with a history of gross hemoptysis (defined as bright red blood or greater than or equal to ½ teaspoon).
• •The patient has a serious non-healing wound ulcer, bone fracture, or major surgical procedure within 30 days prior to first dose of study medication.
• •Elective or planned major surgery to be performed during the course of the trial.
• •The patient has a pre-existing neuropathy \>grade 1.
• •The patient, if a woman, is pregnant or lactating.