Bevacizumab and Carboplatin/Paclitaxel and Radiation in Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00578149|
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : December 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bevacizumab and Carboplatin/Paclitaxel and Radiation in Stage III Non-Small Cell Lung Cancer|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
- To examine the time to progression of the novel regimen in stage III patients treated with concurrent chemoradiotherapy.
- Response rate, overall survival, and patterns of failure and toxicity of the novel therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578149
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Aaron Allen, MD||Dana-Farber Cancer Institute|