Immunoreactivity to Cetuximab in Cancer Patients

Vanderbilt University Medical Center

Status: Completed

Conditions: Head and Neck Cancer; Colorectal Cancer

Treatments: Other: immunologic technique; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00896896

VICC HN 0668

VU-VICC-HN-0668

Details and patient eligibility

About

RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.

PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.

Full description

OBJECTIVES:

• To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.

OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.

Enrollment: 538 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of one of the following:

  • Head and neck cancer
  • Advanced colorectal cancer

• Previously treated with cetuximab

• Serum samples available from patients enrolled in one of the following clinical trials:

  • VU-VICC-GI-0410 (colorectal cancer)
  • VU-VICC-GI-0622 (colorectal cancer)
  • VU-VICC-HN-0356 (head and neck cancer)

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics