Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients
- 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
- 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
- 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
- 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
- Subjects have liver damage or severe kidney failure