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Trial of Aspirin and Arginine Restriction in Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00578721
Recruitment Status : Unknown
Verified June 2017 by jzell, University of California, Irvine.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2007
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
jzell, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 21, 2007
Last Update Posted Date June 8, 2017
Study Start Date  ICMJE September 24, 2008
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
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 colon cancer patients [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT00578721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
To determine this intervention's side-effect profile in a population of optimally-treated colon cancer patients. We expect to demonstrate biomarker alterations without clinical side effects [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Aspirin and Arginine Restriction in Colorectal Cancer
Official Title  ICMJE Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Aspirin
325 mg taken daily with an arginine-restricted diet
Study Arms  ICMJE Experimental: 325 mg Aspirin
325 mg aspirin po qd with arginine-restricted diet
Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00578721
Other Study ID Numbers  ICMJE UCI 07-47
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party jzell, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Zell, MD Chao Family Comprehensive Cancer Center
PRS Account University of California, Irvine
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP