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:
Eastern Cooperative Oncology Group
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
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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 |
| 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) |
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 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 May 23, 2013