Biomakers in Tissue Samples From Patients With Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck Previously Treated With Cisplatin With or Without Cetuximab
Recruitment status was: Not yet recruiting
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab.
Head and Neck Cancer
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: medical chart review
|Official Title:||Retrospective Analysis of ERCC1 Expression in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Who Received Cisplatin or Cisplatin and Cetuximab|
- Association between ERCC1 expression (low or high) with clinical outcomes [ Designated as safety issue: No ]
- Correlation between IHC H-score analysis and AQUA expression of ERCC1 [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- To investigate the association between ERCC1 expression and clinical outcomes (response rate, progression-free survival, and overall survival) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who received cisplatin with versus without cetuximab on clinical trial ECOG-E5397.
OUTLINE: Archived tumor tissue samples are analyzed for ERCC1 expression by IHC. ERCC1 levels (low or high) are assessed by an H-score and AQUA, a quantitative IHC analysis. Each patient's ERCC1 level result is then compared with the patient's clinical outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192750
|Principal Investigator:||Ranee Mehra, MD||Fox Chase Cancer Center|