Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

This study is the first to assess the perioperative time course of systemic inflammation and
immunity in colon cancer patients and evaluate the effect of anti-inflammatory treatment with
celecoxib on this response. In addition, evaluation of the effect of short-term preoperative
administration of celecoxib on tumor immunogenicity will help us to understand how
tumor-enhancing inflammation and anti-tumor immunity can be differentially affected by COX-2
inhibitors. The knowledge gained as a result of this research will help us to set up the
infrastructure for a method to monitor the immunoinflammatory status of colon cancer patients
with a longer term goal of designing interventions to suppress tumor-enhancing inflammation
and vitalize anti-tumor immunity in the perioperative period. The long-term objective is to
use these novel tools in order to improve cancer-specific survival in patients with colon
cancer after primary tumor resection.

Inclusion Criteria:

- Colon cancer patients with no evidence of metastasis in distant organs (i.e., TNM stage
I-III), who are

- between 18 and 75 years old,

- have a body mass index (BMI) between 18 and 35 kg/m^2,

- and are eligible for laparoscopically-assisted colectomy for primary tumor resection.

- Patients must have the ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

- A history of allergic-type reactions to celecoxib or sulphonamides,

- a history of asthma, skin reactions or other allergic reactions to aspirin or other
NSAIDs,

- a history of thromboembolic event (cerebrovascular accident, transient ischemic
attack,

- unstable angina, myocardial infarction, deep vein thrombosis, or pulmonary embolism),

- renal insufficiency (defined by a serum creatinine level > 1.5 mg/dL or blood urea
nitrogen level > 22 mg/dL),

- active gastrointestinal bleeding in the 60 days before surgery,

- alcohol or drug abuse, and

- previous chemotherapy or abdominal/pelvic radiation therapy.

- After randomization, other exclusion criteria will include a surgical procedure longer
than 6 h, inability to extubate the trachea within 4 h after operation, evidence of a
new postoperative myocardial infarction, abnormal postoperative mental status or any
new neurologic deficit, significant postoperative bleeding (with a hemoglobin level <
7.5 g/dL), requiring blood transfusion, or a urine output of less than 30 mL/h.