Clinical trial NCT01284504: Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer
Official title: The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Colon Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling
timeFrame: 2 years
measure: Blood Samples Taken Before Initiation of Study, Day of Surgery, Days 1 and 3 Post-op, and 30 Days Post-op. Analyzed for 50 Serum Cytokines, Cell-specific Gene Expression, and TCR Repertoire.
timeFrame: 30 days
Secondary outcomes:
measure: Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.
timeFrame: 30 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Anthony Doufas
role: PRINCIPAL_INVESTIGATOR
References: