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

Eastern Cooperative Oncology Group

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Other: immunohistochemistry staining method; Drug: cisplatin; Genetic: microarray analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Biological: cetuximab

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01466244

CDR0000715505

ECOG-E5397T3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Treated on protocol ECOG-E5397

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics