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Spots Global Cancer Trial Database for Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

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Trial Identification

Brief Title: Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

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

Study ID: NCT00255229

Interventions

Glutamine
Placebo

Study Description

Brief 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%.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cross Cancer Institute, Edmonton, Alberta, Canada

Contact Details

Name: Michael Sawyer, MD

Affiliation: AHS Cancer Control Alberta

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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