S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Patients must have histologically or cytologically proven newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) or stage IV, advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, or unspecified) or recurrent disease after previous surgery and/or irradiation; patients with tumors having squamous cell components > 50% are not eligible
• Patients with known brain metastases are not eligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration
• Patients may have measurable or non-measurable disease documented by CT, MRI, X-ray or physical exam; measurable disease must be assessed within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Form #848)
• Patients must not have received any prior systemic chemotherapy or biologic therapy for non-small cell lung cancer; patients must not have received any adjuvant therapy for non-small cell lung cancer
• Prior radiation is permitted; however, at least three weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all associated toxicities at time of registration; measurable or non-measurable disease must be outside the previous radiation field or a new lesion must be present
• At least four weeks must have elapsed since surgery (thoracic or other major surgeries) and patients must have recovered from all associated toxicities at the time of registration; measurable disease must be present outside the area of surgical resection; there must be no anticipation of need for major surgical procedures during protocol treatment
• Patients must not have received prior cetuximab, ZD1839, erlotinib or other investigational agents that target the EGFR pathway; patients must not have received prior VEGF-related agents; patients must not have received prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA)
• ANC >= 1,500/mcl
• Platelet count >= 100,000/mcl
• Hemoglobin >= 9 mg/dl
• Patients must have a serum creatinine = = 50 cc/min using the Cockroft-Gault Formula
• Urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be = 1/2 teaspoon within 3 months prior to registration
• Patients must not have >= grade 2 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria Version 3.0)
• Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
• Patients must not have the following: history (within past 6 months) of CVA, myocardial infarction or unstable angina; uncontrolled hypertension; New York Heart Association grade 2 or greater congestive heart failure; serious cardiac arrhythmia requiring medication; or clinically significant peripheral vascular disease
• Patients must not have had an open biopsy or significant traumatic injury within 28 days prior to registration; patients must not have had a core biopsy within 7 days prior to registration
• Patients must not have serious or non-healing wound, ulcer or bone fracture
• Patients must not have history of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to registration
• Patients must have no known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies
• Patients must not have evidence of bleeding diathesis or coagulopathy
• Patients must be willing to provide prior smoking history as required on the S0536 Prestudy Form (Form #54655)
• No other prior malignancy