Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301

Eastern Cooperative Oncology Group

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Genetic: in situ hybridization; Genetic: gene expression analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01487733

ECOG-E4L10T1

CDR0000717143

Details and patient eligibility

About

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.

Full description

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).

Enrollment: 155 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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