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

Phase 2
18 Years
80 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

- 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To demonstrate a > 50% decrease in rectal tissue putrescine levels from baseline in study subjects, as a measure of polyamine reduction in the target tissue of colorectal cancer patients

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jason Zell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

UCI 07-47



Start Date:

September 2008

Completion Date:

December 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • aspirin
  • Colorectal Neoplasms



Chao Family Comprehensive Cancer Center Orange, California  92868