Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients

Inclusion Criteria:

- Subjects must be 18-80 years of age with a history of surgically removed colon or
rectal cancer, and have received treatment for their disease using drugs (adjuvant
chemotherapy)

- Subjects must have colon or rectal cancer with stage I, II, or III disease

- Subjects should not have further treatment with radiation therapy. Subjects having
already received adjuvant (i.e., post-operative) radiation therapy to the colon or
rectum will be excluded. However, subjects receiving radiation therapy prior to
surgery for rectal cancer are eligible for enrollment.

- Subject's tumor must have been completely removed within the past 12 months, with
first surveillance colonoscopy anticipated 12 weeks after study treatment start date
(i.e. one-year after surgical removal).

- Subjects must be in good physical status

- If subjects are premenopausal and perimenopausal women, they must be using adequate
birth control methods.

- Subjects must have no history of another invasive cancer within 5 years

- Subjects must have no further chemotherapy anticipated.

- Subjects don't have special dietary requirements or additives. Subjects must not be
consuming a diet that would preclude taking the study medication.

- Subjects must have no concomitant use of calcium supplements (> 520mg/day).

- Subjects must have no history of abnormal wound healing or repair, or conditions that
predispose to the same.

- Subjects don't have personal history of colon resection of or inflammatory bowel
disease.

- Subjects must give informed consent via consent form approved by the local Human
Subjects Committee (Institutional Review Board).

- If subjects are taking aspirin 81mg by mouth daily they will be eligible

- Subjects must have no history of allergies or adverse reactions to aspirin.

- Subjects don't have documented history of gastric/duodenal ulcer within the last 12
months.

Exclusion Criteria:

- Subjects already received radiation therapy to the colon or rectum.

- Subjects adhering to vegetarian diets.

- Subjects are pregnant or lactating women.

- Subjects are breastfeeding

- Subjects are already taking aspirin 325mg by mouth daily.

- Subjects are taking combination medication with more than 81mg aspirin.

- Subjects are currently being treated for gastric/duodenal ulcer or experiencing
symptoms at study entry.

- Subjects have a history of any medical condition that would place them at risk as a
result of a blood donation, they will be excluded from the study.

- Subjects are taking blood-thinning drugs as warfarin (Coumadin)

- Subjects are allergic to fenoprofen, ibuprofen, indomethacin, ketoprofen,
meclofenamate sodium, naproxen, sulindac, tolmetin, or an orange food coloring known
as tartrazine.

- Subjects have liver damage or severe kidney failure