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Celecoxib in Treating Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00653250
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : May 21, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vicki Keedy, MD, Vanderbilt-Ingram Cancer Center

Study Description
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Brief Summary:

RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying celecoxib in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: celecoxib Procedure: biopsy Procedure: therapeutic conventional surgery Not Applicable

Detailed Description:

OBJECTIVES:

  • To assess cyclo-oxygenase-2 (COX-2) activity in patients with early-stage non-small cell lung cancer (NSCLC) and correlate the results with serum vascular endothelial growth factor (VEGF) levels, tumor microvessel density score, tumor prostaglandin E2 (PGE_2) and matrix metalloproteinases (MMP) levels, and the major urinary metabolite of PGE_2, PGE-M.
  • To assess the effect of specific COX-2 inhibitors (celecoxib) on COX-2 expression within the primary tumor, serum VEGF levels and tumor microvascular density, tumor PGE_2 and MMP levels, and urinary PGE-M in a cohort of patients with early-stage NSCLC.

OUTLINE: Patients receive oral celecoxib 400 mg twice a day for 5 days in the absence of disease progression or unaccepted toxicity. Patients with early-stage disease then undergo surgery.

Biopsy, serum, and urine samples are obtained at baseline and after celecoxib treatment. The biopsy specimen are examined for the expression of cyclo-oxygenase-2 (COX-2), PGE_2, and selected MMPs by immunohistochemistry, western blotting, and northern blotting. Serum and urine samples are analyzed for VEGF and PGE-M expression. COX-2 tumor expression is correlated with serum VEGF levels; tumor MMP-2, MMP-9, and PGE_2 expression; urinary PGE-M and microvessel density scores.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COX-2 Activity in Early and Advanced NSCLC and The Effect of Short-Term Administration of Specific COX-2 Inhibitors (Celecoxib)
Study Start Date : December 2000
Actual Primary Completion Date : March 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Therapeutic Intervention
Correlative
 Drug: celecoxib
400 mg P.O. BID for five days prior to obtaining second serum/urine collection (starting after initial biopsy, serum and urine collection)
Other Name: celebrex

Procedure: biopsy
in patients with newly diagnosed NSCLC, a pretreatment excision of a small amount of tumor tissue

Procedure: therapeutic conventional surgery
surgery to remove the lung tumor
Other Name: tumor resection


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of expression of cyclo-oxygenase-2 (COX-2) activity with serum VEGF levels, tumor microvessel density score, tumor PEG2 and MMP levels, and urinary PGE-M [ Time Frame: Date of pretreatment biopsy surgery (tissue) and day 1 (blood) ]
    COX-2 will be measured in pre-treatment tumor biopsy tissue as well as tumor microvessel density, MMP-2 and PGE2. VEGF will be measured in pre-treatment blood.


Secondary Outcome Measures :
  1. Effect of Celecoxib on COX-2 expression and microvascular density in tumor, PGE2 and MMP levels in tumor, serum VEGF levels and urinary PGE-M [ Time Frame: After day 5 of 5 days of treatment ]
    Patients with early-stage NSCLC will undergo tumor resection after 5 days of treatment with celecoxib. Tumor tissue will be examined. Post-treatment blood and urine will also be collected and examined.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Presumed histological or cytological diagnosis of non-small cell lung cancer

    • Diagnosis to be confirmed upon study entry to collect biopsy material for correlative studies
  • Stage I-IIIA disease

PATIENT CHARACTERISTICS:

  • ECOG performance status of 0-2
  • Serum creatinine ≤ 1.5 mg/dL
  • Granulocytes ≥ 1,500/mm^3
  • Platelets ≥ 100,000/mm^3
  • AST ≤ 3 times normal
  • Bilirubin ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active unresolved infection

PRIOR CONCURRENT THERAPY:

  • At least 7 days since prior and no concurrent non-steroidal anti-inflammatory agents or other cyclo-oxygenase-2 inhibitors
  • At least 7 days since prior parenteral antibiotics
  • No prior systemic chemotherapy or radiotherapy
Contacts and Locations
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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): NCT00653250


Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Vicki Keedy, MD Vanderbilt-Ingram Cancer Center
More Information
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Responsible Party: Vicki Keedy, MD, Assistant Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00653250    
Other Study ID Numbers: VICC THO 0055
P50CA090949 ( U.S. NIH Grant/Contract )
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0055
VU-VICC-000724
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013
Keywords provided by Vicki Keedy, MD, Vanderbilt-Ingram Cancer Center:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action