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
Conditions
Head and Neck Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: fluorescence in situ hybridization Type: Genetic
Name: gene expression analysis Type: Genetic
Name: polymerase chain reaction Type: Genetic
Name: protein analysis Type: Genetic
Name: protein expression analysis Type: Genetic
Name: enzyme-linked immunosorbent assay Type: Other
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Not yet recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Start Date
September 2010
Sponsors
Eastern Cooperative Oncology Group
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page