Study of Blood and Tissue Samples From Patients With Locally Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Treated With Bevacizumab, Carboplatin, and Paclitaxel

NCT ID: NCT00900172

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

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-15

Study Completion Date

2009-04-15

Brief Summary

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RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory 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 and tissue samples from patients with locally advanced, metastatic, or recurrent non-small cell lung cancer treated with bevacizumab, carboplatin, and paclitaxel.

Detailed Description

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OBJECTIVES:

Primary

* To determine whether germline polymorphisms (DNA) of genes involved in DNA repair (e.g., XPD, ERCC-1, and others) and angiogenesis (e.g., vascular endothelial growth factor \[VEGF\], interleukin-8, CXCR2, adrenomedullin, leptin, and others) are associated with toxicity and clinical outcome in patients with non-small cell lung cancer enrolled on protocol ECOG-4599.

OUTLINE: Blood samples previously obtained from patients on protocol ECOG-4599 are analyzed for the association of germline variations of genes involved in DNA repair (XPD and ERCC1), angiogenesis (VEGF and IL-8), and clinical outcome (overall survival, response, progression-free survival, and toxicity).

Tumor cells are collected from paraffin-embedded tissue using laser-capture microdissection and normal tissue is collected from the specimen. Polymorphisms in ERCC-1, XRCC-1, XRCC-3, GST-P1, TGF-β, and IL-8CXCR are assessed using Taqman assays.

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

gene expression analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Available serum or plasma samples from patients with locally advanced, metastatic, or recurrent non-squamous non-small cell lung cancer

* Stage IIIB (with pleural effusion) or stage IV disease
* Enrolled on protocol ECOG-4599

* Treated with carboplatin and paclitaxel with or without bevacizumab

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy
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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Heinz-Josef Lenz, MD

Role: STUDY_CHAIR

University of Southern California

Other Identifiers

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ECOG-E4599T1

Identifier Type: -

Identifier Source: secondary_id

CDR0000592945

Identifier Type: -

Identifier Source: org_study_id

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