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

Proteomic Prediction of Clinical Benefit in HNSCC

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00896675

Enrollment

352

Registered

2009-05-12

Start date

2007-06-30

Completion date

2009-12-31

Last updated

2013-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, salivary gland squamous cell carcinoma, stage IV salivary gland cancer, recurrent salivary gland cancer

Brief summary

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.

Detailed 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.

Interventions

OTHERproteomic profiles

blood samples analysis

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Identification of patients who will benefit from treatment with EGFR and/or VEGF inhibitors based on serum proteomic profiles	upon analysis of each patient tissue collection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026