Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer
- Estimate the objective response rate in patients receiving vinflunine and cetuximab as
second-line therapy for stage IIIB or IV non-small cell lung cancer.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the duration of overall response in these patients.
OUTLINE: This is a multicenter study.
Patients receive vinflunine IV over 15-20 minutes on day 1 and cetuximab IV over 60-120
minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence
of disease progression or unacceptable toxicity. Patients with responding disease may
receive additional courses beyond 4 courses at the discretion of the principal investigator.
After completion of study therapy, patients are followed periodically for 6 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall tumor response rate as assessed by RECIST criteria
Baseline, after cycle 2, within 2 weeks of completing cycle 4
Thomas E. Stinchcombe, MD
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Alamance Oncology/Hematology Associates, LLP||Burlington, North Carolina 27216|