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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01487733
First received: December 6, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Genetic: gene expression analysis
Genetic: in situ hybridization
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Treatment response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival endpoints (e.g., overall survival and progression-free survival) [ Designated as safety issue: No ]

Estimated Enrollment: 155
Study Start Date: January 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01487733

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Athanassios Argiris, MD The University of Texas Health Science Center at San Antonio
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01487733     History of Changes
Other Study ID Numbers: CDR0000717143, ECOG-E4L10T1
Study First Received: December 6, 2011
Last Updated: December 6, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014