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NCT01487733 Clinical Trial

Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301

Head and Neck Cancer Clinical Trial

Official title:
Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01487733
Other study ID # CDR0000717143
Secondary ID ECOG-E4L10T1
Status Completed
Phase N/A
First received December 6, 2011
Last updated May 16, 2017
Start date December 22, 2011
Est. completion date January 22, 2012

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 predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.

Description:

OBJECTIVES:

- To investigate the association between biomarkers (HPV tumor status and ERCC1 expression) and clinical outcomes in a population of patients with recurrent or metastatic head and neck cancer.

- To develop the ability to select patients likely to respond to therapy and to avoid treatment with ineffective therapies, especially since these therapies have substantial toxicity.

- To estimate response and survival rates of HPV-negative and -positive patients in each study. (exploratory)

OUTLINE: Tumor HPV status is determined by in situ hybridization (ISH) and all samples also undergo immunostaining for p16. ERCC1 expression is evaluated with AQUA, a quantitative IHC analysis.

Samples are classified into two categories based on their biomarker status: HPV tumor status (negative versus positive), and ERCC1 expression level (low versus high).

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date January 22, 2012
Est. primary completion date January 22, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Tissue specimens from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301

- Stage III, IV, or recurrent disease

- Squamous cell disease

- Any of the following diagnoses:

- Lip and oral cavity

- Oropharynx

- Hypopharynx

- Larynx

- Paranasal sinus and nasal cavity

- Squamous neck cancer

- Salivary gland

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• gene expression analysis

• in situ hybridization

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment response 1 year
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