Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: gene expression analysis Type: Genetic
Name: in situ hybridization Type: Genetic
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Not yet recruiting
Summary
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.
Detailed 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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Start Date
January 2012
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