NCT Number: NCT00578149
Bevacizumab and Carboplatin/Paclitaxel and Radiation in 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).
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
About this study
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
carboplatin
Drugpaclitaxel
DrugPrimary outcomes
-
To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
Secondary outcomes
-
Response rate, overall survival, and patterns of failure and toxicity of the novel therapy.
Sponsors and collaborators
Lead sponsor
Dana-Farber Cancer Institute
Other
Collaborators
- Brigham and Women's Hospital
- Massachusetts General Hospital
Registry information
Official study title
Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Dec 21, 2007
- Registry last updated
- Dec 21, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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