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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619618
First Posted: June 14, 2012
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
  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
Study Design: Observational Model: Other
Time Perspective: Other
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 Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • The prevalence of c-MET, ABCG2, and K-ras polymorphisms or mutation status summarized by frequency and percentage for all samples [ Time Frame: 1 year ]
  • Association of c-MET, ABCG2, and K-ras polymorphisms or mutation status with toxicity using Fisher's exact test [ Time Frame: 1 year ]
  • Association between biomarkers and time to event distribution estimated by by Kaplan-Meier and estimated by log-rank tests [ Time Frame: 1 year ]
  • Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards [ Time Frame: 1 year ]

Enrollment: 183
Actual Study Start Date: June 1, 2012
Study Completion Date: July 1, 2012
Primary Completion Date: July 1, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients accrued to E1302 from which specimens were submitted for research.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619618


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jill Kolesar, PharmD University of Wisconsin, Madison
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01619618     History of Changes
Other Study ID Numbers: CDR0000734898
ECOG-E1302T1
First Submitted: June 12, 2012
First Posted: June 14, 2012
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group:
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