HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598
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|ClinicalTrials.gov Identifier: NCT00896909|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2017
RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.
|Condition or disease||Intervention/treatment|
|Lung Cancer||Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis|
- Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
- Correlate mutations with time to progression and survival of these patients.
OUTLINE: This is a multicenter study.
Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.
PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Evaluation of HER2 Mutations in Patient Tumors From E2598|
|Actual Study Start Date :||February 2, 2006|
|Actual Primary Completion Date :||July 2, 2006|
|Actual Study Completion Date :||July 2, 2006|
- Correlation of HER-2 mutation with response, time to progression, and survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896909
|Study Chair:||David P. Carbone, MD, PhD||Vanderbilt-Ingram Cancer Center|