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

Jonsson Comprehensive Cancer Center

Status: Terminated

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Apricoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT01532362

11-002081

Details and patient eligibility

About

The primary objective for this trial is to determine the biological ability of apricoxib to decrease T reg cells in the peripheral blood and tumor infiltrating lymphocytes in subjects compared to those who have not in subjects with early stage Non-small Cell Lung Cancer (NSCLC). The secondary objectives are to determine the efficacy of apricoxib to inhibit CD4+CD25+ T reg and FOXP3 function and exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 xULN).
• 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 enrollment.

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 administration.
• Chronic or concurrent use of steroids (topical steroids are acceptable if medically indicated).
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Apricoxib

Experimental group

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.

Treatment:

Drug: Apricoxib

No drug intervention

Other group

Treatment:

Drug: Apricoxib