Finding studies
Finding studies
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Lead
Radiation Therapy Oncology Group
With
OBJECTIVES: Primary * Determine the feasibility of cetuximab when administered concurrently with paclitaxel, carboplatin, and radiotherapy, in terms of safety and compliance, in patients with unresectable stage IIIA or IIIB non-small cell lung cancer. Secondary * Determine the response rate (complete and partial) in patients treated with this regimen. * Determine the overall survival (1- and 2-year survival rate and median survival) of patients treated with this regimen. * Determine the time to disease progression (at 1 and 2 years) in patients treated with this regimen. * Correlate epidermal growth factor receptor expression with the toxicity of this regimen and response, overall survival, and progression in these patients. OUTLINE: This is a multicenter study. * Cetuximab loading dose (week 1): Patients receive a loading dose of cetuximab IV over 2 hours on day 1. * Concurrent cetuximab and chemoradiotherapy (weeks 2-8): Patients receive cetuximab IV over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50-53. * Consolidation therapy (weeks 9-17): Patients receive cetuximab IV over 1 hour on days 57, 64, 71, 78, 85, 92, 99, 106, and 113. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 78 and 99. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days, every 3 months for 2 years, every 4 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
