Clinical trial NCT01192750: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: recurrent metastatic squamous neck cancer with occult primary
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent verrucous carcinoma of the larynx
recurrent verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the larynx
stage IV verrucous carcinoma of the oral cavity
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-09-01
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E5397 from whom samples were submitted for research

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between ERCC1 expression (low or high) with clinical outcomes
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fox Chase Cancer Center
name: Ranee Mehra, MD
role: PRINCIPAL_INVESTIGATOR
References: