Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.

Condition or disease	Intervention/treatment
Head and Neck Cancer	Genetic: fluorescence in situ hybridization; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: protein analysis; Genetic: protein expression analysis; Other: enzyme-linked immunosorbent assay; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

Primary

• To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303, including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.
• To correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival).

OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.

Study Design

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Study Type :	Observational
Actual Enrollment :	69 participants
Observational Model:	Other
Time Perspective:	Retrospective
Official Title:	Molecular Correlates of Response to C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck (E3303): A Phase II Trial of Eastern Cooperative Oncology Group
Actual Study Start Date :	August 5, 2010
Actual Primary Completion Date :	September 5, 2010
Actual Study Completion Date :	September 5, 2010

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Correlation of biomarkers and clinical outcome [ Time Frame: 1 month ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Samples from patients enrolled on E3303 from whom samples were submitted for research

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of squamous cell carcinoma of the head and neck

  • Stage IV disease
  • Unresectable disease
• Treated with cetuximab, cisplatin, and radiotherapy on clinical trial ECOG-E3303
• Archived blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

ECOG-ACRIN Cancer Research Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Jennifer R. Grandis, MD	University of Pittsburgh

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier:	NCT01194635 History of Changes
Other Study ID Numbers:	CDR0000683306; ECOG-E3303T1
First Posted:	September 3, 2010
Last Update Posted:	May 17, 2017
Last Verified:	May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

stage IV squamous cell carcinoma of the lip and oral cavity; stage IV verrucous carcinoma of the oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx	stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx

Additional relevant MeSH terms:

Carcinoma, Squamous Cell; Head and Neck Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms	Neoplasms, Squamous Cell; Neoplasms by Site; Cisplatin; Cetuximab; Antineoplastic Agents