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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


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of squamous cell carcinoma of the head and neck

- Stage IV disease

- Unresectable disease

- Treated with cetuximab, cisplatin, and radiotherapy on clinical trial ECOG-E3303

- Archived blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Correlation of biomarkers and clinical outcome

Safety Issue:

No

Principal Investigator

Jennifer R. Grandis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

Unspecified

Study ID:

CDR0000683306

NCT ID:

NCT01194635

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

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