Study of Blood and Tissue Samples From Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Treated With Bevacizumab, Carboplatin, and Paclitaxel
|ClinicalTrials.gov Identifier: NCT00900172|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
RATIONALE: Studying samples of blood and 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 will respond to treatment.
PURPOSE: This research study is looking at blood and tissue samples from patients with locally advanced, metastatic, or recurrent non-small cell lung cancer treated with bevacizumab, carboplatin, and paclitaxel.
|Condition or disease||Intervention/treatment|
|Lung Cancer||Biological: bevacizumab Drug: carboplatin Drug: paclitaxel Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis|
- To determine whether germline polymorphisms (DNA) of genes involved in DNA repair (e.g., XPD, ERCC-1, and others) and angiogenesis (e.g., vascular endothelial growth factor [VEGF], interleukin-8, CXCR2, adrenomedullin, leptin, and others) are associated with toxicity and clinical outcome in patients with non-small cell lung cancer enrolled on protocol ECOG-4599.
OUTLINE: Blood samples previously obtained from patients on protocol ECOG-4599 are analyzed for the association of germline variations of genes involved in DNA repair (XPD and ERCC1), angiogenesis (VEGF and IL-8), and clinical outcome (overall survival, response, progression-free survival, and toxicity).
Tumor cells are collected from paraffin-embedded tissue using laser-capture microdissection and normal tissue is collected from the specimen. Polymorphisms in ERCC-1, XRCC-1, XRCC-3, GST-P1, TGF-β, and IL-8CXCR are assessed using Taqman assays.
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Official Title:||Angiogenesis Pathway Gene Polymorphisms Associated With Clinical Outcome in Patients Enrolled in ECOG 4599|
|Actual Study Start Date :||March 15, 2008|
|Primary Completion Date :||April 15, 2009|
|Study Completion Date :||April 15, 2009|
- Correlation of results to response and toxicity [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900172
|Study Chair:||Heinz-Josef Lenz, MD||University of Southern California|