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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Eastern Cooperative Oncology Group
- Enrollment
- 42
- Primary Endpoint
- Cetuximab activity as reflected in RR
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cetuximab activity as reflected in RR
Time Frame: 1 year