Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397

Study Overview
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Brief Summary
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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 patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.

Detailed Description
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OBJECTIVES: Primary Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers. Secondary Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient and PTEN-expressing cancers, by treatment arm. OUTLINE: Tissue microarray slides collected earlier from ECOG-E5397 are immunostained with PTEN antibody and analyzed with AQUA.

Official Title
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PTEN Determination in Squamous Cell Cancer of The Head and Neck Treated on E5397, A Randomized Phase III Trial of Cisplatin Plus Placebo Versus Cisplatin Plus C225 (Cetuximab) in Metastatic/Recurrent Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: cetuximab
* Drug: cisplatin
* Genetic: gene expression analysis
* Genetic: microarray analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Treated on protocol ECOG-E5397 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: cetuximab|nan|
|Drug: cisplatin|nan|
|Genetic: gene expression analysis|nan|
|Genetic: microarray analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cetuximab activity as reflected in RR |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, 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, untreated metastatic squamous neck cancer with occult primary