Bevacizumab and Carboplatin/Paclitaxel and Radiation in Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT00578149
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
- Secondary Outcome Measures
Name Time Method Response rate, overall survival, and patterns of failure and toxicity of the novel therapy.
Trial Locations
- Locations (2)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States