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Studying Biomarkers in Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on E1302 Trial

Evaluation of Polymorphisms and Mutations in Genes Postulated to Alter the Efficacy of Gefitinib in Samples From E1302

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01619618
Enrollment
183
Registered
2012-06-14
Start date
2012-06-01
Completion date
2012-07-01
Last updated
2017-05-17

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 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

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.

Interventions

GENETICmutation analysis
GENETICpolymerase chain reaction
GENETICpolymorphism analysis
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Eastern Cooperative Oncology Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards1 year
The prevalence of c-MET, ABCG2, and K-ras polymorphisms or mutation status summarized by frequency and percentage for all samples1 year
Association of c-MET, ABCG2, and K-ras polymorphisms or mutation status with toxicity using Fisher's exact test1 year
Association between biomarkers and time to event distribution estimated by by Kaplan-Meier and estimated by log-rank tests1 year

Outcome results

None listed

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