Bevacizumab and Carboplatin/Paclitaxel and Radiation in Non-Small Cell Lung Cancer

Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer

This study is being done to learn what effects (good and bad) bevacizumab in conjunction with carboplatin/paclitaxel and radiation therapy has on patients with non-small cell lung cancer (NSCLC).

• There are three phases of treatment 1)chemoradiation, 2) consolidation and 3)maintenance therapy.
• The chemoradiation phase is from week 1 to week 7. The following will occur during this phase: Daily chest radiation starting on day 1; pre-medication for paclitaxel; weekly intravenous administration of paclitaxel and carboplatin; intravenous administration of bevacizumab once weekly every three weeks starting on day 1.
• During weeks 8-9, patients will undergo a PET/CT scan for restaging.
• The consolidation phase is from week 10 to week 16. The following will occur during this phase: Pre-medication for paclitaxel; intravenous administration of paclitaxel and carboplatin twice weekly every 3 weeks; intravenous administration of bevacizumab once weekly every 3 weeks.
• The maintenance phase is from week 17 to week 52. The following will occur during this phase; intravenous administration of bevacizumab once a week every three weeks for 1 year; PET/CT scan every three months.
• The following evaluations will occur during treatment: 1)Patients will be evaluated weekly by the study doctor, 2) Weight, difficulty or discomfort in swallowing, shortness of breath and over well-being will be recorded, 3) Weekly lab test will include CBC, chemistries, and liver function tests. 4) Followed through each cycle of chemotherapy and every 6-8 weeks for the duration of the study.
• The following evaluations will occur after treatment: 1)Every 6-8 weeks assessed for response with a CT or PET/CT scan for one year, 2) Toxicity will also be assessed at each follow-up interval.

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer (NSCLC) that have been evaluated and determined not to be candidates for surgical resection as part of their definitive management of stage III disease.
• Age 18 years or older
• ECOG performance status of 0-1
• Life Expectancy of greater than six months
• Normal organ and marrow function
• Women and men of child-bearing potential must agree to use adequate contraception

Exclusion Criteria:

• Prior chemotherapy or thoracic radiation therapy
• Squamous histology or any histology in close proximity to a major vessel
• Active hemoptysis
• History of hypercoagulability
• Known distant metastatic disease
• History of allergic reactions attributed to compounds with similar chemical or biological composition to bevacizumab, carboplatin, paclitaxel or other agents used in this study
• Patients with uncontrolled intercurrent illness
• Pregnant women
• Major surgical procedure, open biopsy, or significant traumatic injury with in 28 days prior to day 0
• Minor surgical procedure within 7 days to day 0
• HIV-positive patients receiving combination anti-retroviral therapy.
• Non-skin cancer malignancy in the past 5 years.