Clinical trial NCT00653250: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-04
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Date of pretreatment biopsy surgery (tissue) and day 1 (blood)
Secondary outcomes:
measure: 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
timeFrame: After day 5 of 5 days of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Vicki Keedy, MD
role: PRINCIPAL_INVESTIGATOR
References: