Trial Information
Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)
OBJECTIVES:
- To investigate the association between biomarkers (HPV tumor status and ERCC1
expression) and clinical outcomes in a population of patients with recurrent or
metastatic head and neck cancer.
- To develop the ability to select patients likely to respond to therapy and to avoid
treatment with ineffective therapies, especially since these therapies have substantial
toxicity.
- To estimate response and survival rates of HPV-negative and -positive patients in each
study. (exploratory)
OUTLINE: Tumor HPV status is determined by in situ hybridization (ISH) and all samples also
undergo immunostaining for p16. ERCC1 expression is evaluated with AQUA, a quantitative IHC
analysis.
Samples are classified into two categories based on their biomarker status: HPV tumor status
(negative versus positive), and ERCC1 expression level (low versus high).
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Tissue specimens from patients with recurrent or metastatic head and neck cancer
treated on ECOG-E1395 and ECOG-E3301
- Stage III, IV, or recurrent disease
- Squamous cell disease
- Any of the following diagnoses:
- Lip and oral cavity
- Oropharynx
- Hypopharynx
- Larynx
- Paranasal sinus and nasal cavity
- Squamous neck cancer
- Salivary gland
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Treatment response
Safety Issue:
No
Principal Investigator
Athanassios Argiris, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Texas Health Science Center at San Antonio
Authority:
Unspecified
Study ID:
CDR0000717143
NCT ID:
NCT01487733
Start Date:
January 2012
Completion Date:
Related Keywords:
- Head and Neck Cancer
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- salivary gland squamous cell carcinoma
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the hypopharynx
- stage IVA squamous cell carcinoma of the larynx
- stage IVA squamous cell carcinoma of the lip and oral cavity
- stage IVA squamous cell carcinoma of the oropharynx
- stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVB squamous cell carcinoma of the larynx
- stage IVB squamous cell carcinoma of the lip and oral cavity
- stage IVB squamous cell carcinoma of the oropharynx
- stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVC squamous cell carcinoma of the larynx
- stage IVC squamous cell carcinoma of the lip and oral cavity
- stage IVC squamous cell carcinoma of the oropharynx
- stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IVA salivary gland cancer
- stage IVB salivary gland cancer
- stage IVC salivary gland cancer
- Head and Neck Neoplasms