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Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)


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

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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

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