Official Title: “Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea”

Irinotecan (7-ethyl-10- {4(-1-piperidino)-1-piperidino} carbonyloxy camptothecin) is a semisynthetic camptothecin derivative introduced in the 1980's.

Irinotecan is a prodrug metabolized by carboxylesterases to an active metabolite 7-ethyl-10-hydroxy-camptothecin (SN38). SN38 exerts its cytotoxic effect by forming stable complexes with topoisomerase I and DNA. These complexes collide with replication forks and cause breaks in DNA. Studies substantiated irinotecan's activity in 5FU resistant colorectal cancer and led to its approval for treatment of 5FU resistant colorectal cancer in the United States, Canada and Europe.Colorectal cancer studies demonstrated that single agent irinotecan's dose limiting toxicity was diarrhea occurring 5 to 6 days after its administration. High dose loperamide at first occurrence of diarrhea has decreased the incidence of diarrhea but the incidence of grade 3/4 diarrhea remains high at 28 to 40%.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Glutamine
  • Glutamine 10 g four times daily starting two days before treatment for six days in total
• Other: Placebo
  • Glutamine placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Irinotecan, 5FU, Glutamine
• Placebo Comparator: 2
  • Irinotecan, 5FU, Placebo

Primary Measures

• Reduction in diarrhea.
  • Time Frame: Study completion
    

Inclusion Criteria:

• metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

• severely abnormal liver and kidney function

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alberta Cancer Board

Overall Clinical Trial Officials and Contacts

Michael Sawyer, MD Principal Investigator Alberta Cancer Board  

Overall Contact: Michael Sawyer, MD 780-432-8726 michsawy@cancerboard.ab.ca

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00255229

Study ID Number: GI-05-0024

ClinicalTrials.gov Identifier: NCT00255229

Health Authority: Canada: Health Canada