Colon Cancer, Colorectal Cancer
Conditions
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.
Interventions
DRUGCelecoxib
200 mg tablet oral
OTHERplacebo
Placebo, tab
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Participant flow
Recruitment details
1 patient was consented but withdrew before treatment assignment (randomization), none were treated.
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib Celecoxib, 200 mg tab
Celecoxib: 200 mg tablet oral | 1 |
| Placebo placebo, tab
placebo: Placebo, tab | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Celecoxib | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: One patient was accrued and withdrawn after signing consent; none were treated.
Primary
Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling
Time frame: 2 years
Population: One patient was accrued and withdrawn after signing consent; none were treated.
Secondary
Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.
Time frame: 30 days
Population: One patient was accrued and withdrawn after signing consent; none were treated.