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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

ClinicalTrials.gov Identifier:

NCT01194635

First received: September 2, 2010

Last updated: May 16, 2017

Last verified: May 2017

History of Changes

Purpose

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	Intervention
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


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: head and neck squamous cell carcinoma

MedlinePlus related topics: Head and Neck Cancer

Drug Information available for: Cisplatin Cetuximab

Genetic and Rare Diseases Information Center resources: Nasopharyngeal Carcinoma Laryngeal Cancer Hypopharyngeal Cancer

U.S. FDA Resources

Further study details as provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

Primary Outcome Measures:

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


Enrollment:	69
Actual Study Start Date:	August 5, 2010
Study Completion Date:	September 5, 2010
Primary Completion Date:	September 5, 2010 (Final data collection date for primary outcome measure)

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194635

Sponsors and Collaborators

ECOG-ACRIN Cancer Research Group

National Cancer Institute (NCI)

Investigators


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

More Information


Responsible Party:	ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier:	NCT01194635 History of Changes
Other Study ID Numbers:	CDR0000683306 ECOG-E3303T1
Study First Received:	September 2, 2010
Last Updated:	May 16, 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

ClinicalTrials.gov processed this record on September 21, 2017

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