Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy
Recruitment status was: Not yet recruiting
RATIONALE: Studying samples of blood and tumor 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 understand how patients respond to treatment.
PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.
Head and Neck Cancer
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: protein analysis
Genetic: protein expression analysis
Other: enzyme-linked immunosorbent assay
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Official Title:||Molecular Correlates of Response to C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck (E3303): A Phase II Trial of Eastern Cooperative Oncology Group|
- Correlation of biomarkers and clinical outcome [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
- To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303, including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.
- To correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival).
OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194635
|Principal Investigator:||Jennifer R. Grandis, MD||University of Pittsburgh|