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Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

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:
NCT01124669
First received: May 14, 2010
Last updated: May 16, 2017
Last verified: May 2017
  Purpose

RATIONALE: Studying samples of blood 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 blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.


Condition Intervention
Lung Cancer Genetic: DNA analysis Genetic: mutation analysis Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR [ Time Frame: 1 mont ]
  • Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response) [ Time Frame: 1 month ]

Enrollment: 80
Actual Study Start Date: June 13, 2010
Study Completion Date: July 13, 2010
Primary Completion Date: July 13, 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
  • To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.

OUTLINE: This is a multicenter study.

DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

  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 E2501
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of refractory non-small cell lung cancer
  • Received sorafenib tosylate on protocol ECOG-E2501
  • Available blood specimens

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: NCT01124669

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christine Chung, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT01124669     History of Changes
Other Study ID Numbers: CDR0000670998
ECOG-E2501T2
Study First Received: May 14, 2010
Last Updated: May 16, 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV 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
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017