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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:
Eastern Cooperative Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01619618
First received: June 12, 2012
Last updated: May 16, 2017
Last verified: May 2017
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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:
MedlinePlus related topics:
Head and Neck Cancer
Genetic and Rare Diseases Information Center resources:
Nasopharyngeal Carcinoma
Laryngeal Cancer
Hypopharyngeal Cancer
Metastatic Squamous Neck Cancer With Occult Primary
U.S. FDA Resources
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) |
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 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01619618
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | June 12, 2012 |
| Last Updated: | May 16, 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 |
ClinicalTrials.gov processed this record on September 21, 2017