Bevacizumab and Carboplatin/Paclitaxel and Radiation in Non-Small Cell Lung Cancer
NCT ID: NCT00578149
Last Updated: 2007-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2006-05-31
2007-08-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Bevacizumab
Carboplatin
Paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Principal Investigators
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Aaron Allen, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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05-415
Identifier Type: -
Identifier Source: org_study_id