- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01466244
Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397
PTEN Determination in Squamous Cell Cancer of The Head and Neck Treated on E5397, A Randomized Phase III Trial of Cisplatin Plus Placebo Versus Cisplatin Plus C225 (Cetuximab) in Metastatic/Recurrent Head and Neck Cancer
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers.
Secondary
- Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient and PTEN-expressing cancers, by treatment arm.
OUTLINE: Tissue microarray slides collected earlier from ECOG-E5397 are immunostained with PTEN antibody and analyzed with AQUA.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Treated on protocol ECOG-E5397
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cetuximab activity as reflected in RR
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Barbara A. Burtness, MD, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage III squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVA squamous cell carcinoma of the larynx
- stage IVA squamous cell carcinoma of the lip and oral cavity
- stage IVA squamous cell carcinoma of the oropharynx
- stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVB squamous cell carcinoma of the larynx
- stage IVB squamous cell carcinoma of the lip and oral cavity
- stage IVB squamous cell carcinoma of the oropharynx
- stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IVC squamous cell carcinoma of the larynx
- stage IVC squamous cell carcinoma of the lip and oral cavity
- stage IVC squamous cell carcinoma of the oropharynx
- stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000715505
- ECOG-E5397T3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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