Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer

You may not be if

• 2. Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy
• 3. Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.
• 4. Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration.
• 5. Male or female patients \>=18 years of age.
• 6. Life expectancy of at least 3 months.
• 7. ECOG performance status of \<=1.
• 8. Measurable disease by RECIST criteria (see Section 7).
• 9. Laboratory values as follows:
• * ANC \>=1500/mm3 (7 days prior to treatment);
• * Hemoglobin \>=8 g/dL;
• * Platelets \>=100,000 mm3 (7 days prior to treatment)
• * Bilirubin \<=1 x ULN for institution
• * AST/SGOT \<=2.5 x ULN or \<=5.0 x ULN in patients with liver metastases and
• * ALT/SGPT \<=2.5 x ULN or \<=5.0 x ULN in patients with liver metastases
• * Creatinine \<=2.0 mg/dL or
• * Calculated (measured) GFR \>=40 mL/min
• * PT/INR and PTT \<=1.5 x ULN
• 10. Peripheral neuropathy \<= grade 1.
• 1. A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of \> grade 2 per New York Heart Association (NYHA) criteria (see Appendix B), myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
• 2. Metastatic brain or meningeal tumors.
• 3. Uncontrolled intercurrent illness.
• 4. Chemotherapy, investigational drug therapy, or major surgery ≤ 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy.
• 5. Patient is \<=5 years free of another primary malignancy, except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
• 1. Patients with squamous cell histology NSCLC.
• 2. Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 1 month of beginning bevacizumab.
• 3. Patients who have had primary thoracic radiation within 3 months of beginning bevacizumab.
• 4. Fine needle aspiration, core biopsy, mediastinoscopy or other minor surgical procedure within 7 days of beginning bevacizumab.
• 5. Patients receiving thrombolytic therapy within 10 days of starting bevacizumab.
• 6. Patients with serious non-healing wound, ulcer, or bone fracture.
• 7. Patients with evidence of bleeding diathesis or coagulopathy.
• 8. Patients with history of hemoptysis (defined as bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment.
• 9. Patients with proteinuria at screening, as demonstrated by either:
• * Urine protein : creatinine (UPC) ratio \>=1.0 or
• * Urine dipstick for protein \>=2+ (patients discovered to have \>=2+ proteinuria on dipstick at baseline should undergo a 24-hour urine collection, and must demonstrate \<1 g of protein in 24 hours to be eligible).
• 10. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.