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

This study is not yet open for participant recruitment.
Verified June 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01619618
First received: June 12, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Evaluation of Polymorphisms and Mutations in Genes Postulated to Alter the Efficacy of Gefitinib in Samples From E1302

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • The prevalence of c-MET, ABCG2, and K-ras polymorphisms or mutation status summarized by frequency and percentage for all samples [ Designated as safety issue: No ]
  • Association of c-MET, ABCG2, and K-ras polymorphisms or mutation status with toxicity using Fisher's exact test [ Designated as safety issue: No ]
  • Association between biomarkers and time to event distribution estimated by by Kaplan-Meier and estimated by log-rank tests [ Designated as safety issue: No ]
  • Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards [ Designated as safety issue: No ]

Estimated Enrollment: 183
Study Start Date: May 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619618

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Jill Kolesar, PharmD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01619618     History of Changes
Other Study ID Numbers: CDR0000734898, ECOG-E1302T1
Study First Received: June 12, 2012
Last Updated: June 12, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014