Non-Small Cell Lung Cancer
Conditions
Keywords
chemoradiotherapy, Lung cancer
Brief summary
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).
Detailed description
* 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.
Interventions
DRUGBevacizumab
DRUGCarboplatin
DRUGPaclitaxel
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, overall survival, and patterns of failure and toxicity of the novel therapy. | — |
Countries
United States
Outcome results
None listed