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

NCT01194635 | Completed

• 2 other identifiers: CDR0000683306ECOG-E3303T1
• Study Type: observational
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation of biomarkers and clinical outcome

  1 month

Interventions

fluorescence in situ hybridization GENETIC

gene expression analysis GENETIC

polymerase chain reaction GENETIC

protein analysis GENETIC

protein expression analysis GENETIC

enzyme-linked immunosorbent assay OTHER

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

In Situ Hybridization, Fluorescence; Gene Expression Profiling; Polymerase Chain Reaction; Enzyme-Linked Immunosorbent Assay; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Nucleic Acid Amplification Techniques; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Molecular Probe Techniques; Histocytochemistry

Study Officials

• Jennifer R. Grandis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: August 5, 2010
• Primary Completion: September 5, 2010
• Study Completion: September 5, 2010
• Last Updated: May 17, 2017

Record last verified: 2017-05