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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900172
First received: May 9, 2009
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00900172

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Heinz-Josef Lenz, MD University of Southern California
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00900172     History of Changes
Other Study ID Numbers: CDR0000592945, ECOG-E4599T1
Study First Received: May 9, 2009
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014