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NCT01466257 Clinical Trial

Biomarkers in Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01466257
Other study ID # CDR0000715520
Secondary ID ECOG-E5397T2
Status Completed
Phase N/A
First received November 2, 2011
Last updated May 17, 2017
Start date November 21, 2011
Est. completion date January 1, 2012

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date January 1, 2012
Est. primary completion date January 1, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Treated on protocol ECOG-E5397

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• cetuximab

Drug:
• cisplatin

Genetic:
• DNA analysis

• gene expression analysis

• mutation analysis

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Mutation rates of HRAS and PIK3CA 1 day
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