Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00897533
Last Updated: 2017-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
137 participants
OBSERVATIONAL
2007-04-13
2008-04-13
Brief Summary
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PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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gene mapping
polymorphism analysis
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
Eligibility Criteria
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Inclusion Criteria
* 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
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Jill Kolesar, PharmD
Role: STUDY_CHAIR
University of Wisconsin, Madison
References
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Amann JM, Lee JW, Roder H, Brahmer J, Gonzalez A, Schiller JH, Carbone DP. Genetic and proteomic features associated with survival after treatment with erlotinib in first-line therapy of non-small cell lung cancer in Eastern Cooperative Oncology Group 3503. J Thorac Oncol. 2010 Feb;5(2):169-78. doi: 10.1097/JTO.0b013e3181c8cbd9.
Other Identifiers
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ECOG-E3503T1
Identifier Type: -
Identifier Source: secondary_id
CDR0000543981
Identifier Type: -
Identifier Source: org_study_id
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