Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea
Information source: AHS Cancer Control Alberta
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Colorectal Cancer
Intervention: Glutamine (Drug); Placebo (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Alberta Health Services Official(s) and/or principal investigator(s): Michael Sawyer, MD, Principal Investigator, Affiliation: AHS Cancer Control Alberta
Summary
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%.
Clinical Details
Official title: Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Reduction in diarrhea.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- metastatic colorectal cancer to be treated with FOLFIAT chemo
Exclusion Criteria:
- severely abnormal liver and kidney function
Locations and Contacts
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada
Additional Information
Starting date: December 2002
Last updated: January 5, 2012
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