Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Metastatic Colorectal Cancer Clinical Trial

Official title:

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255229
• Other study ID #: GI-05-0024
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2005
• Last updated: February 24, 2016
• Start date: December 2002
• Est. completion date: January 2010

Study information

• Verified date: January 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

• severely abnormal liver and kidney function

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Colorectal Cancer

Intervention

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

Other:
• Placebo
Glutamine placebo

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in diarrhea.		Study completion	No