NCT01619618

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

June 12, 2012

Last Update Submit

May 16, 2017

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxstage IVA squamous cell carcinoma of the larynxstage IVB squamous cell carcinoma of the larynxstage IVC squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavitystage IVA squamous cell carcinoma of the lip and oral cavitystage IVB squamous cell carcinoma of the lip and oral cavitystage IVC squamous cell carcinoma of the lip and oral cavityrecurrent metastatic squamous neck cancer with occult primaryrecurrent squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxstage IVA squamous cell carcinoma of the oropharynxstage IVB squamous cell carcinoma of the oropharynxstage IVC squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage IVA squamous cell carcinoma of the paranasal sinus and nasal cavitystage IVB squamous cell carcinoma of the paranasal sinus and nasal cavitystage IVC squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent salivary gland cancerstage IVA salivary gland cancerstage IVB salivary gland cancerstage IVC salivary gland cancer

Outcome Measures

Primary Outcomes (4)

  • The prevalence of c-MET, ABCG2, and K-ras polymorphisms or mutation status summarized by frequency and percentage for all samples

    1 year

  • Association of c-MET, ABCG2, and K-ras polymorphisms or mutation status with toxicity using Fisher's exact test

    1 year

  • Association between biomarkers and time to event distribution estimated by by Kaplan-Meier and estimated by log-rank tests

    1 year

  • Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards

    1 year

Interventions

mutation analysisGENETIC
polymerase chain reactionGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples from patients accrued to E1302 from which specimens were submitted for research.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckSalivary Gland Neoplasms

Interventions

Polymerase Chain ReactionAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesDNA Fingerprinting

Study Officials

  • Jill Kolesar, PharmD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 17, 2017

Record last verified: 2017-05