Clinical trial NCT00898911: Blood Sample Analysis in Predicting Overall Survival in Patients With Recurrent or Metastatic Head and Neck Cancer
Official title: Prediction of Overall Survival Using Mass Spectrometry Profiling in Head and Neck Cancer Patients Treated With Epidermal Growth Factor Receptor Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the 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
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
stage IV salivary gland cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients enrolled on E3301

Brief summary: RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood sample analysis in predicting overall survival in patients with recurrent or metastatic head and neck cancer.

Detailed description: OBJECTIVES:

* To validate the mass spectrometry profile that is predictive of survival benefit in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with EGFR inhibitors.

OUTLINE: Plasma and serum samples are analyzed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and classified according to prognosis ("good" vs "poor") using a previously developed predictive algorithm.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma
* Meets 1 of the following criteria:

  * Enrolled on clinical trial ECOG-E3301 and previously treated with irinotecan hydrochloride and docetaxel
  * Enrolled on clinical trial VU-VICC-HN-0501 and previously treated with docetaxel and bortezomib
* Plasma and serum samples available for analysis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Overall survival measured in weeks
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Christine Chung, MD
role: STUDY_CHAIR
References: