Blood Proteins in Predicting Treatment Benefit in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer

Vanderbilt University Medical Center

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Other: proteomic profiles

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00896675

VICC HN 0744

VU-VICC-070359

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-HN-0744

Details and patient eligibility

About

RATIONALE: Studying samples of blood in the laboratory may help doctors learn more about cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at proteins in blood samples to predict treatment benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.

Full description

OBJECTIVES:

• To identify head and neck squamous cell cancer patients who will benefit from treatment with the EGFR inhibitors (i.e., erlotinib hydrochloride, gefitinib, and cetuximab) and VEGF inhibitor (i.e., bevacizumab), based on predictive proteomic profiles in patient blood samples.

OUTLINE: This is a multicenter study.

Blood samples are analyzed for proteomic profile to determine good and bad prognoses in patients treated with or without EGFR inhibitors and/or a VEGF inhibitor.

Enrollment: 352 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of squamous cell head and neck cancer

  • Recurrent and/or metastatic disease

• Meets 1 of the following criteria:

  • Previously treated with EGFR inhibitors and/or VEGF inhibitor on 1 of the following clinical trials, and has available blood samples:

    • A Phase I/II Study of Bevacizumab (rhu MAb VEGF) in Combination With OSI-774 for Patients With Recurrent or Metastatic Cancer of the Head and Neck
    • A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

  • Previously treated with cetuximab and has blood samples available from protocol VU-VICC-HN-0356

  • Previously treated with conventional chemotherapy and has blood samples available from protocol VU-VICC-HN-0356

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

352 participants in 2 patient groups

patients treated with EGFR inhibitors and/or VEGF inhibitor

Treatment:

Other: proteomic profiles

Other: proteomic profiles

NOT treated with EGFR inhibitors and/or VEGF inhibitor

Treatment:

Other: proteomic profiles

Other: proteomic profiles