Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

This study has been withdrawn prior to enrollment.
(low accrual rate; the only participant withdrew after signing consent)
Sponsor:
Information provided by (Responsible Party):
Anthony Doufas, Stanford University
ClinicalTrials.gov Identifier:
NCT01284504
First received: January 25, 2011
Last updated: June 23, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Colon Cancer
Drug: Celecoxib

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Tumor sample - Analyzed for TCR Repertoire and Global Transcription Profiling [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surveys to evaluate patient pain, fatigue, and quality of recovery, recorded from day of surgery to 30 days post-op. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celocoxib Drug: Celecoxib
200 mg tablet oral
Other Names:
  • Celebrex
  • Celebra
  • Onsenal
Placebo Comparator: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01284504

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Anthony Doufas Stanford University
  More Information

No publications provided

Responsible Party: Anthony Doufas, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01284504     History of Changes
Other Study ID Numbers: COL0001, SU-10182010-7110, 19588
Study First Received: January 25, 2011
Last Updated: June 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014