Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment with erlotinib.
PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.
Genetic: gene mapping
Genetic: polymorphism analysis
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method
|Official Title:||Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503|
- Mesenchymal and epithelial markers [ Designated as safety issue: No ]
- Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) [ Designated as safety issue: No ]
- Prediction of progression-free survival (PFS) by mesenchymal and epithelial markers [ Designated as safety issue: No ]
- Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
- Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
- Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
- Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
- Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.
OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.
PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897533
|Study Chair:||Jill Kolesar, PharmD||University of Wisconsin, Madison|