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Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

Primary Purpose

Colorectal Cancer, Colon Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Celecoxib

placebo

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Celecoxib

Placebo

Arm Description

Celecoxib, 200 mg tab

placebo, tab

Outcomes

Primary Outcome Measures

Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01284504

First Posted

January 25, 2011

Last Updated

February 19, 2018

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01284504

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Terminated

Why Stopped

low accrual rate; the only participant withdrew after signing consent

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Colon Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Celecoxib

Arm Type

Experimental

Arm Description

Celecoxib, 200 mg tab

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo, tab

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Other Intervention Name(s)

Celebrex, Celebra, Onsenal

Intervention Description

200 mg tablet oral

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Placebo, tab

Primary Outcome Measure Information:

Title

Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling

Time Frame

2 years

Title

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

30 days

Secondary Outcome Measure Information:

Title

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Doufas

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

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