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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: January 2010
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
Outcome Measures for this Clinical Trial
Primary Measures
- Reduction in diarrhea.
- Time Frame: Study completion
Safety Issue?: No
- Time Frame: Study completion
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Alberta Health Services Other
Overall Clinical Trial Officials and Contacts
Michael Sawyer, MD Principal Investigator Alberta Health Services
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00255229
