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

NCT ID: NCT01619618

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-01

Study Completion Date

2012-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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mutation analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill Kolesar, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

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ECOG-E1302T1

Identifier Type: -

Identifier Source: secondary_id

CDR0000734898

Identifier Type: -

Identifier Source: org_study_id

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