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NCT01192750 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01192750
Other study ID # CDR0000683281
Secondary ID ECOG-E5397T1
Status Completed
Phase N/A
First received August 31, 2010
Last updated May 16, 2017
Start date August 5, 2010
Est. completion date October 5, 2010

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

OBJECTIVES:

- 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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date October 5, 2010
Est. primary completion date October 5, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of squamous cell carcinoma of the head and neck

- Recurrent and/or metastatic disease

- Received cisplatin with or without cetuximab on clinical trial ECOG-E5397

- Slides and blocks of tumor specimens available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

• medical chart review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Association between ERCC1 expression (low or high) with clinical outcomes 1 month
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