A Phase II Study Of Cetuximab (C225) In Combination With Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
- 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.
- Determine the response rate (complete and partial) in patients treated with this
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
George R. Blumenschein, MD
M.D. Anderson Cancer Center
United States: Federal Government
|Arlington Cancer Center - Arlington||Arlington, Texas 76012|