Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer|
- Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR). [ Time Frame: Baseline, after cycle 2, within 2 weeks of completing cycle 4 ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.
- Duration of Response [ Time Frame: After cycle 4 ]
- Overall Survival [ Time Frame: Every 30 days ]
- Progression-free Survival [ Time Frame: after cycle 2, within 2 weeks of completing cycle 4 ]
|Study Start Date:||August 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Experimental: Vinflunine + Cetuximab
Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
400 mg/m² week 1,then 250 mg/m² weekly
Other Name: erbituxDrug: vinflunine
Vinflunine 320 mg/m² every 21 days
Other Name: Javlor
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519831
|United States, North Carolina|
|Alamance Oncology/Hematology Associates, LLP|
|Burlington, North Carolina, United States, 27216|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||Thomas E. Stinchcombe, MD||UNC Lineberger Comprehensive Cancer Center|