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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
celecoxib
biopsy
therapeutic conventional surgery
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Therapeutic Intervention

    Arm Description

    Correlative

    Outcomes

    Primary Outcome Measures

    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
    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

    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
    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.

    Full Information

    First Posted
    April 3, 2008
    Last Updated
    May 20, 2013
    Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00653250
    Brief Title
    Celecoxib in Treating Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
    Official Title
    COX-2 Activity in Early and Advanced NSCLC and The Effect of Short-Term Administration of Specific COX-2 Inhibitors (Celecoxib)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2000 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic Intervention
    Arm Type
    Experimental
    Arm Description
    Correlative
    Intervention Type
    Drug
    Intervention Name(s)
    celecoxib
    Other Intervention Name(s)
    celebrex
    Intervention Description
    400 mg P.O. BID for five days prior to obtaining second serum/urine collection (starting after initial biopsy, serum and urine collection)
    Intervention Type
    Procedure
    Intervention Name(s)
    biopsy
    Intervention Description
    in patients with newly diagnosed NSCLC, a pretreatment excision of a small amount of tumor tissue
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic conventional surgery
    Other Intervention Name(s)
    tumor resection
    Intervention Description
    surgery to remove the lung tumor
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    Date of pretreatment biopsy surgery (tissue) and day 1 (blood)
    Secondary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    After day 5 of 5 days of treatment

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vicki Keedy, MD
    Organizational Affiliation
    Vanderbilt-Ingram Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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