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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

Page last updated: August 23, 2015

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