Know Cancer

or
forgot password

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


N/A
N/A
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome 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.

Outcome Time Frame:

Date of pretreatment biopsy surgery (tissue) and day 1 (blood)

Safety Issue:

No

Principal Investigator

Vicki Keedy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC THO 0055

NCT ID:

NCT00653250

Start Date:

December 2000

Completion Date:

January 2008

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location