Studying Biomarkers in Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on E1302 Trial
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| ClinicalTrials.gov Identifier: NCT01619618 |
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Recruitment Status
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Completed
First Posted
: June 14, 2012
Last Update Posted
: May 17, 2017
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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 or disease | Intervention/treatment |
|---|---|
| Head and Neck Cancer | Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis |
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 : | Observational |
| Actual Enrollment : | 183 participants |
| 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 |
| Actual Study Start Date : | June 1, 2012 |
| Actual Primary Completion Date : | July 1, 2012 |
| Actual Study Completion Date : | July 1, 2012 |
- 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 ]
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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 |
DISEASE CHARACTERISTICS:
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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
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
| Principal Investigator: | Jill Kolesar, PharmD | University of Wisconsin, Madison |
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01619618 History of Changes |
| Other Study ID Numbers: |
CDR0000734898 ECOG-E1302T1 |
| First Posted: | June 14, 2012 Key Record Dates |
| Last Update Posted: | May 17, 2017 |
| Last Verified: | May 2017 |
Keywords provided by Eastern Cooperative Oncology Group:
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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:
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Head and Neck Neoplasms Neoplasms by Site Neoplasms |