Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study aims to investigate how the administration of a drug known to reduce inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a patient undergoing primary tumor resection surgery for colon cancer. The proposed project is an exploratory study, and will use data from blood samples and tumor samples to attempt to elucidate the immune and inflammatory response in colon cancer patients undergoing primary resection of their tumors.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Celecoxib

Criteria

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.