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
OBJECTIVES:
Primary
- 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.
Observational
N/A
Correlation of biomarkers and clinical outcome
No
Jennifer R. Grandis, MD
Principal Investigator
University of Pittsburgh
Unspecified
CDR0000683306
NCT01194635
September 2010
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