Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib
Condition: Colorectal Adenoma; Colorectal Carcinoma
MeSH terms: Carcinoma; Adenoma; Colorectal Neoplasms
Intervention: Celecoxib; Placebo
Intervention description: 400 mg twice a day for 7 days prior to surgery; one tablet of placebo will be given for 7 days prior to surgery
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess how effective celecoxib is in limiting production of a
      hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in
      the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression
      of an existing cancer. To answer this question, some subjects are given the new
      investigational drug, and other subjects a placebo. A placebo is a capsule that contains
      inactive ingredients. Only by comparing the response of two subject groups, one receiving
      placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or
      not celecoxib actually works. The outcome we are assessing is the hormone activity before and
      after celecoxib is given.
    

Eligibility criteria:

        Inclusion criteria:

          1. Mass suspicious for carcinoma, clinical diagnosis of adenocarcinoma of the colon (to
             be histologically confirmed upon study entry) or an adenoma that is not removable by
             endoscopy.

          2. Patient must be undergoing colo-rectal resection

          3. age > 18yrs

          4. Karnofsky performance status(KPS) > 60.

          5. Signed and dated informed consent.

          6. Complete history and physical examination within 30 days of study entry.

          7. Laboratory evaluations within 30 days of study entry to include: Complete Blood
             Count(CBC) with differential and platelets, Blood Urea Nitrogen(BUN), creatinine,
             bilirubin, serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic
             transaminase(SGPT), lactate dehydrogenase(LDH), alkaline phosphatase, total protein,
             albumin and carcinoembryonic antigen(CEA).

          8. Chest x-ray within 30 days of study entry.

          9. The subject has no other serious medical illness, other than that treated by this
             study, which would limit the ability of the patient to receive protocol therapy, or
             psychiatric condition which would prevent informed consent.

        Absolute exclusion criteria:

          1. severe infection ;White Blood Cell Count(WBC) > 2 times normal, fever, sepsis)

          2. immunosuppression (steroids, transplant patient)

          3. emergent operation(perforation, obstruction).

          4. Patients with serum bilirubin or creatinine levels greater than two times the normal
             upper limit would be excluded.

          5. Pregnant or lactating women or subjects of child bearing age who do not practice
             effective means of birth control

          6. Sulfonamide allergy

          7. Recurrent or previous history of known ischemic heart disease or thrombotic events as
             well as any angioplasty or cardiac by-pass procedures in the previous 12 months.

        Relative exclusion criteria:

          1. Medications taken by the patient that are listed in section 9.0 of this protocol would
             be reviewed by the enlisting physician prior to entry into the study. Warfarin,
             aspirin and methotrexate would be stopped prior to protocol entry as these are stopped
             prior to any surgery. The most common of the listed medications would be ACE
             inhibitors and furosemide. The dose, schedule and indications of the medications would
             be reviewed with the patient and a decision regarding entry into the study would be
             made by the enlisting physician. Other less common medications will be similarly
             reviewed, however most had little or no clinical side effects despite potential
             biochemical interactions.

          2. Medications known to be COX inhibitors would have to be stopped prior to entry into
             the study. This would include any aspirin,nonsteroidal antiinflammatory drugs(NSAID)
             (ibuprofen, naproxen, rofecoxib, celecoxib, Mobic, etc) or over the counter cold
             medication that might contain these substances. A list of common over-the-counter
             medications that might contain such substances will be reviewed with the patient and
             if there are any questions after the study has begun, instructions to call before
             taking any medications will be given.