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Biomarker Study of Blood Samples From Patients With Non-Small Cell Lung Cancer Treated With Carboplatin and Paclitaxel With or Without Bevacizumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898417
First Posted: May 12, 2009
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
  Purpose

RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for non-small cell lung cancer may help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at proteomic patterns in stored blood samples from patients undergoing treatment for non-small cell lung cancer.


Condition Intervention
Lung Cancer Biological: bevacizumab Drug: carboplatin Drug: paclitaxel Genetic: proteomic profiling Other: laboratory biomarker analysis Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Development of a Serum Proteomic Classifier for the Prediction of Benefit From Bevacizumab in Combination With Carboplatin and Paclitaxel

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Survival [ Time Frame: 1 day ]

Enrollment: 90
Actual Study Start Date: March 14, 2008
Study Completion Date: April 14, 2008
Primary Completion Date: April 14, 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To develop a serum proteomic classifier using matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry analysis of blood samples from patients with non-squamous cell non-small cell lung cancer to predict benefit, in terms of survival and time to progression, from treatment with bevacizumab in combination with carboplatin and paclitaxel.

Secondary

  • To better quantitate candidate biomarkers by using more advanced mass spectrometric technologies, including multiple-reaction monitoring and heavy-labeled peptides.

OUTLINE: Previously collected pre-treatment samples of serum or plasma are randomly selected from patients enrolled on protocol ECOG-4599 (i.e., 60 from the bevacizumab arm and 30 from the control arm). Samples are analyzed by matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry to identify patterns from protein spectra that correlate with patient survival.

  Eligibility

Information from the National Library of Medicine

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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 participating in E4599
Criteria

DISEASE CHARACTERISTICS:

  • Available serum and plasma samples from patients with previously untreated locally advanced, metastatic, or recurrent non-squamous cell non-small cell lung cancer
  • Enrolled on clinical trial ECOG-4599

    • Treated with carboplatin and paclitaxel with or without bevacizumab

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898417


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: David P. Carbone, MD, PhD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00898417     History of Changes
Other Study ID Numbers: CDR0000592948
ECOG-E4599T2
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
stage IIIB non-small cell lung cancer
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar 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
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors