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

NCT ID: NCT00898417

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-14

Study Completion Date

2008-04-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

proteomic profiling

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David P. Carbone, MD, PhD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Other Identifiers

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ECOG-E4599T2

Identifier Type: -

Identifier Source: secondary_id

CDR0000592948

Identifier Type: -

Identifier Source: org_study_id

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