Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer
Stopped early · Not applicable · Has a placebo group
Conditions studied: Colorectal Cancer, Colon Cancer
In brief
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.
Key facts
- Study ID
- NCT01284504
- Run by
- Stanford University
- People needed
- 1
- Starts
- 2011-01-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2018-03-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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