Biomarkers in Patients With Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
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

November 2, 2011
November 2, 2011
December 2011
January 2012   (final data collection date for primary outcome measure)
Mutation rates of HRAS and PIK3CA [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Biomarkers in Patients With Head and Neck Cancer
Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma

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.

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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Head and Neck Cancer
  • Biological: cetuximab
  • Drug: cisplatin
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Other: laboratory biomarker analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
Not Provided
January 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Treated on protocol ECOG-E5397

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
Not Provided
 
NCT01466257
CDR0000715520, ECOG-E5397T2
Not Provided
Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Christine H. Chung, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
November 2011

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