Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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