Biomarkers in Patients With Head and Neck Cancer

This study is not yet open for participant recruitment.

Verified November 2011 by National Cancer Institute (NCI)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT01466257

First received: November 2, 2011

Last updated: NA

Last verified: November 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 2, 2011

Last Updated Date

November 2, 2011

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mutation rates of HRAS and PIK3CA [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Response rate [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biomarkers in Patients With Head and Neck Cancer

Official Title ^ICMJE

Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma

Brief Summary

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.

Detailed Description

OBJECTIVES:

To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.
To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.

OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Biological: cetuximab
Drug: cisplatin
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: mutation analysis
Other: laboratory biomarker analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Treated on protocol ECOG-E5397

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01466257

Other Study ID Numbers ^ICMJE

CDR0000715520, ECOG-E5397T2

Has Data Monitoring Committee

Not Provided

Responsible Party

Robert L. Comis, ECOG Group Chair's Office

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Christine H. Chung, MD

Sidney Kimmel Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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