Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Colon Cancer
• Intervention / Treatment: Drug: Celecoxib; Other: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celecoxib; Celecoxib, 200 mg tab	Drug: Celecoxib; 200 mg tablet oral; Other Names: Celebrex; Celebra; Onsenal
Placebo Comparator: Placebo; placebo, tab	Other: placebo; Placebo, tab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling	2 years
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.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.	30 days

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: IRB-19588; SU-10182010-7110 (Other Identifier: SU directory); COL0001 (OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No