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

May 16, 2017 updated by: Eastern Cooperative Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples from patients who participated in E1395 or E3301 and provided samples for research.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment response
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Athanassios Argiris, MD, The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 22, 2011

Primary Completion (ACTUAL)

January 22, 2012

Study Completion (ACTUAL)

January 22, 2012

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (ESTIMATE)

December 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000717143
  • ECOG-E4L10T1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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