NCT00519831

Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC

Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	400 mg/m² week 1,then 250 mg/m² weekly
DRUG	vinflunine	Vinflunine 320 mg/m² every 21 days

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-02-01
• Completion: 2009-11-01
• First posted: 2007-08-23
• Last updated: 2017-06-09
• Results posted: 2017-06-09

Locations

2 sites across 1 country: United States