Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397
|ClinicalTrials.gov Identifier: NCT01466244|
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Biological: cetuximab Drug: cisplatin Genetic: gene expression analysis Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers.
- 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 :||Observational|
|Actual Enrollment :||42 participants|
|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|
|Actual Study Start Date :||November 11, 2011|
|Actual Primary Completion Date :||January 11, 2012|
|Actual Study Completion Date :||January 11, 2012|
- Cetuximab activity as reflected in RR [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466244
|Principal Investigator:||Barbara A. Burtness, MD||Fox Chase Cancer Center|