Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, 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 cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer|
- Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone [ Time Frame: 42 days ] [ Designated as safety issue: No ]Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.
- Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Radigoraphic response of measurable disease will be assessed using RECIST critera
- Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]Radigoraphic response of measurable disease will be assessed using RECIST criteria
- Number of subjects experiencing adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Adverse events will be assessed (graded) using CTCAE criteria
|Study Start Date:||July 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
- To estimate the disease-control rate in patients with advanced chemotherapy-naive non-small cell lung cancer after 2 courses of carboplatin, ixabepilone, and cetuximab.
- To estimate the progression-free survival of patients treated with this regimen.
- To estimate the overall survival of patients treated with this regimen.
- To estimate the toxicity of this regimen in these patients.
- To determine the potential predictive marker of efficacy of ixabepilone and cetuximab. (exploratory)
- To investigate the prevalence of cetuximab IgE antibody, and the rate of cetuximab hypersensitivity reactions in patients without evidence of cetuximab IgE antibodies.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and cetuximab IV over 1-2 hours on days 1, 8 and 15. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.
Tumor tissue and blood samples are collected for further analysis.
After completion of study therapy, patients are followed periodically.
|Principal Investigator:||Thomas E. Stinchcombe, MD||UNC Lineberger Comprehensive Cancer Center|