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

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
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
NCT ID
NCT00653250
First Posted
April 3, 2008
Last Updated
May 20, 2013
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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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