Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503

Conditions
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Lung Cancer

Intervention / Treatment
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* Genetic: gene mapping
* Genetic: polymorphism analysis
* Other: diagnostic laboratory biomarker analysis
* Other: immunohistochemistry staining method


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer, including any of the following subtypes: Adenocarcinoma Squamous cell carcinoma Bronchoalveolar carcinoma Carcinoid Stage IIIB or IV or recurrent disease Must have received treatment with erlotinib hydrochloride on clinical trial ECOG-E3503 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene mapping|nan|
|Genetic: polymorphism analysis|nan|
|Other: diagnostic laboratory biomarker analysis|nan|
|Other: immunohistochemistry staining method|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesenchymal and epithelial markers | Mesenchymal and epithelial markers | 1 month | 
| Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) | Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers | 1 month | 
| Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers | Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers | 1 month | 
| Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS | Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, bronchoalveolar cell lung cancer