Lung Cancer Clinical Trial
Official title:
Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some
find tumor cells and help kill them or carry tumor-killing substances to them. Others
interfere with the ability of tumor cells to grow and spread. Giving vinflunine together
with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab
works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell
lung cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
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