HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598
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.
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
|Study Design:||Observational Model: Other
Time Perspective: Retrospective
|Official Title:||Evaluation of HER2 Mutations in Patient Tumors From E2598|
- Correlation of HER-2 mutation with response, time to progression, and survival
|Actual Study Start Date:||February 2, 2006|
|Study Completion Date:||July 2, 2006|
|Primary Completion Date:||July 2, 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896909
|Study Chair:||David P. Carbone, MD, PhD||Vanderbilt-Ingram Cancer Center|