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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alamance Oncology/Hematology Associates, LLP
Burlington, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Start Date
August 1, 2007
Primary Completion Date
February 1, 2008
Completion Date
November 1, 2009
Last Updated
June 9, 2017
18
ACTUAL participants
cetuximab
BIOLOGICAL
vinflunine
DRUG
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
NCT05198830
NCT07190248
Data Source & Attribution
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