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
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|ClinicalTrials.gov Identifier: NCT01192750|
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: medical chart review|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||79 participants|
|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|
|Actual Study Start Date :||August 5, 2010|
|Actual Primary Completion Date :||October 5, 2010|
|Actual Study Completion Date :||October 5, 2010|
- Association between ERCC1 expression (low or high) with clinical outcomes [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192750
|Principal Investigator:||Ranee Mehra, MD||Fox Chase Cancer Center|