Clinical trial NCT01487733: Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
Official title: Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
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
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-07
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients who participated in E1395 or E3301 and provided samples for research.

Brief 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).

Eligibility 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

Primary outcomes:
measure: Treatment response
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Athanassios Argiris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Argiris A, Li S, Ghebremichael M, Egloff AM, Wang L, Forastiere AA, Burtness B, Mehra R. Prognostic significance of human papillomavirus in recurrent or metastatic head and neck cancer: an analysis of Eastern Cooperative Oncology Group trials. Ann Oncol. 2014 Jul;25(7):1410-1416. doi: 10.1093/annonc/mdu167. Epub 2014 May 5.