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OpenTrials
Completed

NCT Number: NCT00653250

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

400 mg P.O. BID for five days prior to obtaining second serum/urine collection (starting after initial biopsy, serum and urine collection)

Other names: celebrex

Biopsy

Procedure

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

therapeutic conventional surgery

Procedure

surgery to remove the lung tumor

Other names: tumor resection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

COX-2 Activity in Early and Advanced NSCLC and The Effect of Short-Term Administration of Specific COX-2 Inhibitors (Celecoxib)

Important dates

Study start
2000
Primary completion
2006
Study completion
2008
First posted
Apr 4, 2008
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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