Clinical trial NCT01619618: Studying Biomarkers in Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on E1302 Trial
Official title: Evaluation of Polymorphisms and Mutations in Genes Postulated to Alter the Efficacy of Gefitinib in Samples From E1302
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
recurrent squamous cell carcinoma of the larynx
stage IVA squamous cell carcinoma of the larynx
stage IVB squamous cell carcinoma of the larynx
stage IVC squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
stage IVA squamous cell carcinoma of the lip and oral cavity
stage IVB squamous cell carcinoma of the lip and oral cavity
stage IVC squamous cell carcinoma of the lip and oral cavity
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 IVA squamous cell carcinoma of the oropharynx
stage IVB squamous cell carcinoma of the oropharynx
stage IVC squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
stage IVA salivary gland cancer
stage IVB salivary gland cancer
stage IVC salivary gland cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-14
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients accrued to E1302 from which specimens were submitted for research.

Brief summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory 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 laboratory study is looking at biomarkers in samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.

Detailed description: OBJECTIVES:

* To evaluate the frequency of ATP-binding cassette, sub-family G (WHITE), member 2 (ABCG2), met proto-oncogene (hepatocyte growth factor receptor) (c-MET), and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) polymorphisms or mutations in this study population and the predictiveness of these polymorphisms on survival, time to progression, response rate, and toxicities.

OUTLINE: Archived tumor tissue and peripheral blood mononuclear cells are analyzed for the frequency of ABCG2, c-MET, and K-ras polymorphisms or mutations by polymerase chain reaction (PCR). Results are then correlated with patients' clinical outcomes and toxicity.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Patients diagnosed with recurrent or metastatic head and neck cancer treated on Eastern Cooperative Oncology Group (ECOG)-E1302 trial

  * Patients treated with docetaxel with versus without gefitinib
* Existing paraffin blocks and peripheral blood mononuclear cells

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: The prevalence of c-MET, ABCG2, and K-ras polymorphisms or mutation status summarized by frequency and percentage for all samples
timeFrame: 1 year
measure: Association of c-MET, ABCG2, and K-ras polymorphisms or mutation status with toxicity using Fisher's exact test
timeFrame: 1 year
measure: Association between biomarkers and time to event distribution estimated by by Kaplan-Meier and estimated by log-rank tests
timeFrame: 1 year
measure: Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Jill Kolesar, PharmD
role: PRINCIPAL_INVESTIGATOR
References: