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
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Treated on protocol ECOG-E5397
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Cetuximab activity as reflected in RR
Safety Issue:
No
Principal Investigator
Barbara A. Burtness, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
Unspecified
Study ID:
CDR0000715505
NCT ID:
NCT01466244
Start Date:
December 2011
Completion Date:
Related Keywords:
- Head and Neck Cancer
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- recurrent metastatic squamous neck cancer with occult primary
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage III 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
- untreated metastatic squamous neck cancer with occult primary
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
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