Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer

Inclusion:

* Recurrent and/or metastatic resectable colorectal cancer, including disease within the abdomen and pelvis with no evidence of extra-abdominal metastases. Isolated resectable pulmonary metastasis are allowable in the absence of intra-abdominal metastasis. Intra-abdominal disease includes: isolated hepatic metastasis/metastases (see next inclusion criteria point), isolated peritoneal metastasis, peritoneal carcinomatosis (including patients undergoing cytoreductive surgery alone or in combination with hyperthermic intraperitoneal chemoperfusion - HIPEC), or a combination of hepatic and extrahepatic metastasis.
* Patients with isolated hepatic metastasis must satisfy a Clinical Risk Score of 3 or higher (see Appendix C)
* Eligible patients are expected to have a complete resection based on preoperative imaging. Any patient not found to be able to have complete resection will not be eligible for this study.
* No chemotherapy, radiotherapy, major surgery, or biologic therapy within 3 weeks of protocol treatment
* An ECOG performance status of 0, 1, or 2.
* Age equal to 18 years or older.
* Must have normal organ and marrow function as defined below:

  * Platelet ≥ 75,000/µL
  * Hemoglobin ≥ 9.0 g/dL
  * Hematocrit ≥ 27.0%
  * Absolute Neutrophil Count (ANC) ≥ 1500/µL
  * Creatinine \< institutional upper limit of normal (ULN) OR
  * Creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels greater than ULN
  * Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
  * AST(SGOT) and ALT(SGPT) ≤ 2.5 X institutional upper limit of normal (ULN)
  * Serum amylase and lipase within normal limits.
* Patient must be able to understand and be willing to sign a written informed consent document.

Exclusion:

* Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment.
* Patients with active autoimmune disease or history of transplantation.
* Patients who are pregnant or nursing. Women of childbearing potential (WOCBP) will have to undergo a urine pregnancy test as part of screening.
* Patients with comorbid medical conditions that render them unfit for surgery.
* Metastatic or recurrent disease that is deemed partially resectable or unresectable based on preoperative imaging.
* Metastatic disease outside the confines of the abdomen, pelvis and thorax (e.g bone, brain)
* Cardiac risk factors including:

  * Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent
  * Patients with a New York Heart Association classification of III or IV (Appendix A)
* History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Patients with ulceration, bleeding or perforation in the lower bowel are not excluded.
* Prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, or NSAIDs.
* Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average. Low-dose aspirin not exceeding 100 mg/day is permitted. Patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required.