- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619618
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
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
1 year
|
Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jill Kolesar, PharmD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent metastatic squamous neck cancer with occult primary
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- stage IVA squamous cell carcinoma of the larynx
- stage IVA squamous cell carcinoma of the lip and oral cavity
- stage IVA squamous cell carcinoma of the oropharynx
- stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVB squamous cell carcinoma of the larynx
- stage IVB squamous cell carcinoma of the lip and oral cavity
- stage IVB squamous cell carcinoma of the oropharynx
- stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVC squamous cell carcinoma of the larynx
- stage IVC squamous cell carcinoma of the lip and oral cavity
- stage IVC squamous cell carcinoma of the oropharynx
- stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVA salivary gland cancer
- stage IVB salivary gland cancer
- stage IVC salivary gland cancer
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000734898
- ECOG-E1302T1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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