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Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT01123460
First received: May 13, 2010
Last updated: May 16, 2017
Last verified: May 2017
  Purpose

RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.


Condition Intervention
Lung Cancer Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Measurement of Potential Biomarkers Predicting Erlotinib Response

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

Primary Outcome Measures:
  • Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response [ Time Frame: 1 month ]

Enrollment: 127
Actual Study Start Date: April 12, 2010
Study Completion Date: June 12, 2010
Primary Completion Date: June 12, 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride.

OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients enrolled on E3503
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer
  • Received erlotinib hydrochloride on clinical trial ECOG-E3503

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123460

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven M. Dubinett, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT01123460     History of Changes
Other Study ID Numbers: CDR0000670992
ECOG-E3503T2
Study First Received: May 13, 2010
Last Updated: May 16, 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017