Bevacizumab and Erlotinib Followed by Cisplatin or Carboplatin and Gemcitabine in Treating Patients With Newly Diagnosed or Recurrent Stage IIIB or Stage IV NSCLC

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
• * Newly diagnosed or recurrent disease
• Meets 1 of the following staging criteria:
• * Stage IIIB disease, meeting both of the following criteria:
• * Proven malignant effusion or supraclavicular node involvement (i.e., N3 supraclavicular nodes)
• * Not a candidate for curative multimodality treatment or surgery
• * Stage IV disease
• Measurable disease, defined as ≥ 1 lesion (outside of irradiated areas) that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI
• Immediate chemotherapy not clinically mandatory in the judgement of the investigator
• No intrathoracic large, centrally located tumors and/or cavitary lesions invading or abutting major blood vessels
• No evidence of clinically active interstitial lung disease
• * Patients with chronic stable radiographic changes who are asymptomatic are eligible
• No small cell lung cancer (SCLC), squamous NSCLC, or combined SCLC-NSCLC tumors
• No brain metastases
• PATIENT CHARACTERISTICS:
• WHO performance status 0-1
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Thrombocyte count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present)
• Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)
• Quick ≥ 70% OR INR ≤ 1.5
• Creatinine ≤ 2.0 times ULN
• Proteinuria ≤ 2+ by urine dipstick
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after completion of study treatment
• Able to understand trial information given by the investigator and complete quality of life questionnaire
• No pre-existing condition that would preclude swallowing and/or absorption of oral medication
• No prior or concurrent malignancies, except for the following:
• * Malignancy for which the minimum relapse-free interval is ≥ 5 years
• * Nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
• No other medical condition that would preclude study participation, including any of the following:
• * Unstable or uncompensated respiratory, cardiac, hepatic, or renal disease
• * Active infection
• * Uncontrolled diabetes mellitus
• * Hypertension ≥ 150/100 mm Hg despite treatment
• * Myocardial infarction within the past 3 months
• * History of hemorrhagic disorders
• * Non-healing wound, ulcer, or bone fracture
• No clinical history of coagulopathy or thrombosis
• No hemoptysis or hematemesis ≥ grade 2 (defined as bright red blood of ≥ 5 mL per episode) within the past 6 months
• No known hypersensitivity to study drug(s) or to any other component of the study drugs
• No significant traumatic injury within the past 28 days
• No serious underlying medical condition that would impair the ability of the patient to participate in the trial or that would preclude use of study drugs
• No cerebrovascular accident or other CNS bleeding within the past 6 months
• PRIOR CONCURRENT THERAPY:
• At least 4 weeks since prior radiotherapy and recovered
• * No prior radiotherapy to lesion(s) selected for measurement
• No prior chemotherapy for advanced disease
• * At least 6 months since prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC
• * Prior intrapleural or intrapericardial local chemotherapy allowed
• No prior endothelial growth factor and/or vascular endothelial growth factor (receptor)-targeted therapy for NSCLC
• More than 28 days since prior major surgical procedure or open biopsy
• More than 30 days since prior treatment in another clinical trial
• No concurrent anticoagulants (e.g., phenprocoumon, acenocoumarol, or full-dose warfarin or heparin)
• No concurrent full-dose continuous use of non-steroid anti-inflammatory drugs (NSAIDs)
• No concurrent aspirin or clopidogrel bisulfate
• * Low-dose aspirin (≤ 325 mg daily) may be continued in patients at high risk for arterial thromboembolic disease
• No other concurrent drugs contraindicated for use with the study drugs, according to the Swissmedic-approved product information
• No other concurrent experimental drugs or anticancer therapy, including chemotherapy, immunotherapy, or hormone therapy