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NCT00898911 Clinical Trial

Blood Sample Analysis in Predicting Overall Survival in Patients With Recurrent or Metastatic Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Prediction of Overall Survival Using Mass Spectrometry Profiling in Head and Neck Cancer Patients Treated With Epidermal Growth Factor Receptor Inhibitors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00898911
Other study ID # CDR0000600560
Secondary ID ECOG-E3301T1
Status Completed
Phase N/A
First received May 9, 2009
Last updated May 16, 2017
Start date July 8, 2008
Est. completion date April 8, 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 blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood sample analysis in predicting overall survival in patients with recurrent or metastatic head and neck cancer.

Description:

OBJECTIVES:

- To validate the mass spectrometry profile that is predictive of survival benefit in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with EGFR inhibitors.

OUTLINE: Plasma and serum samples are analyzed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and classified according to prognosis ("good" vs "poor") using a previously developed predictive algorithm.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 8, 2012
Est. primary completion date April 8, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma

- Meets 1 of the following criteria:

- Enrolled on clinical trial ECOG-E3301 and previously treated with irinotecan hydrochloride and docetaxel

- Enrolled on clinical trial VU-VICC-HN-0501 and previously treated with docetaxel and bortezomib

- Plasma and serum samples available for analysis

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• matrix-assisted laser desorption/ionization time of flight mass spectrometry

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 Overall survival measured in weeks 1 month
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