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Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer

18 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

Evaluation of Apricoxib (Selective Cyclooxygenase 2 Inhibition) in Modulating T Regulatory Cells of Patients With Early Stage Non-small Cell Lung Cancer

Inclusion Criteria:

- Adults over the age of 18 capable of giving informed consent. Radiographic findings
suspicious for primary lung cancer or pathologically confirmed NSCLC which is
surgically resectable and radiographically early stage (stage I and II).

- ECOG performance status of 0, 1, or 2 (see Appendix A).

- Ineligible for or refuse preoperative chemotherapy or chemoradiation therapy

- Normal renal function (defined as serum creatinine ≤ 2 mg/dl or creatinine clearance
≥ 60 ml/min/1.73m2).

- Normal liver function (defined as total bilirubin ≤ 1.5 x ULN, SGOT & SGPT ≤ 2.5

- Negative pregnancy test prior to initiation of treatment and adequate contraception
throughout treatment.

- Preoperative pulmonary function test (PFT) with FEV1 and D LCO ≥ 60% or predicted
postoperative FEV1 and DLCO ≥ 40% based on quantitative lung perfusion scan

- Must be able to come off anticoagulants and have normal coagulation studies (PTT < 40
seconds and INR < 1.4) prior to planned surgery.

- For subjects on COX-2 inhibitors or other NSAIDS prior to study initiation, cessation
of the drug for 1 week prior to Apricoxib administration is required for study

Exclusion Criteria:

- Radiation therapy, chemotherapy, non-cytotoxic investigational agents, or
corticosteroids within 4 weeks of initiating treatment.

- Comorbid disease or a medical condition that would impair the ability of the subject
to receive or comply with the study protocol.

- Hypersensitivity to apricoxib, sulfonamides, aspirin, or other NSAIDS or to any
reagents used in the study.

- Previous history of gastrointestinal ulceration, bleeding, or perforation.

- Required concurrent use of COX-2 inhibitors or other NSAIDS during Apricoxib

- Chronic or concurrent use of steroids (topical steroids are acceptable if medically

- Pregnant or nursing women.

- Evidence of NYHA class III or greater cardiac disease.

- History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic
conduction abnormality within 12 months of initiating treatment.

- History of heart surgery for coronary artery disease.

- Known HIV infection or AIDS.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Compare level of CD4+CD25high T lymphocyte regulatory cells in peripheral blood lymphocytes and tumor infiltrating lymphocytes from surgical resection specimens of subjects with early stage NSCLC who have received apricoxib to those who have not

Outcome Description:

As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision). Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Jay M Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Jonsson Comprehensive Cancer CenterLos Angeles, California  90095