Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Celecoxib

Celecoxib, 200 mg tab

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

200 mg tablet oral

Placebo

placebo, tab

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Placebo, tab

Interventions

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Celecoxib

200 mg tablet oral

Intervention Type DRUG

placebo

Placebo, tab

Intervention Type OTHER

Other Intervention Names

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Celebrex Celebra Onsenal

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No