- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487733
Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
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
Conditions
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Athanassios Argiris, MD, The University of Texas Health Science Center at San Antonio
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage III squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- stage III salivary gland cancer
- salivary gland squamous cell carcinoma
- metastatic squamous neck cancer with occult primary
- 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
- stage IVA salivary gland cancer
- stage IVB salivary gland cancer
- stage IVC salivary gland cancer
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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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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