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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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ) Identifier:
First received: May 9, 2009
Last updated: May 17, 2017
Last verified: May 2017

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.

Condition Intervention
Lung Cancer
Biological: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Angiogenesis Pathway Gene Polymorphisms Associated With Clinical Outcome in Patients Enrolled in ECOG 4599

Resource links provided by NLM:

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Correlation of results to response and toxicity [ Time Frame: 1 month ]

Enrollment: 180
Actual Study Start Date: March 15, 2008
Study Completion Date: April 15, 2009
Primary Completion Date: April 15, 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


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


  • 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


  • Not specified


  • See Disease Characteristics
  • No prior chemotherapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00900172

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study Chair: Heinz-Josef Lenz, MD University of Southern California
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group Identifier: NCT00900172     History of Changes
Other Study ID Numbers: CDR0000592945
Study First Received: May 9, 2009
Last Updated: May 17, 2017

Keywords provided by Eastern Cooperative Oncology Group:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent 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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
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 processed this record on May 22, 2017