Trial of Aspirin and Arginine Restriction in Colorectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Vanessa Wong, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00578721
First received: December 18, 2007
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The purpose of this research study is to understand the effects of oral aspirin taken daily with an arginine-restricted diet on certain colorectal cancer biomarkers in treated colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence and for development of secondary colorectal cancers in the future. Specific chemicals (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help understand a person's risk for developing colorectal cancer. Specific biomarkers associated with colorectal cancer have been identified in prior laboratory studies. By measuring these predefined biomarkers before and after the study intervention, we can assess how they are affected by the intervention, and gain knowledge about their usefulness in colorectal cancer patients on clinical trial.

This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily with an arginine-restricted diet designed to reduce arginine intake by at least 30% during the 12-week study period. The biomarkers will be obtained from patient by performing endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are done to evaluate changes in tissue content that may relate to early events in colon cancer formation. This was the procedure used to diagnose your condition initially. There will be 24 patients enrolled into this study performed through University of California Irvine Medical Center.


Condition Intervention Phase
Colorectal Cancer
Drug: Aspirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine this intervention's side-effect profile in a population of optimally-treated colorectal cancer patients. We expect to demonstrate biomarker alterations without clinical side effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 325 mg Aspirin
325 mg aspirin po qd with arginine-restricted diet
Drug: Aspirin
325 mg taken daily with an arginine-restricted diet

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578721

Contacts
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center 1-877-UC-STUDY UCstudy@uci.edu

Locations
United States, California
Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Principal Investigator: Jason Zell, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Jason Zell, MD Chao Family Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Vanessa Wong, User Account Contact, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00578721     History of Changes
Other Study ID Numbers: UCI 07-47
Study First Received: December 18, 2007
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Colorectal cancer
aspirin

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014