Clinical trial NCT01466244: Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-11-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E5397 from who samples were submitted for research

Brief summary: 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.

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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Treated on protocol ECOG-E5397

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Cetuximab activity as reflected in RR
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fox Chase Cancer Center
name: Barbara A. Burtness, MD
role: PRINCIPAL_INVESTIGATOR
References: