Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

February 24, 2016 updated by: AHS Cancer Control Alberta
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

  • severely abnormal liver and kidney function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Irinotecan, 5FU, Glutamine
Drug: Glutamine
Glutamine 10 g four times daily starting two days before treatment for six days in total
PLACEBO_COMPARATOR: 2
Irinotecan, 5FU, Placebo
Other: Placebo
Glutamine placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in diarrhea.
Time Frame: Study completion
Study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

November 16, 2005

First Submitted That Met QC Criteria

November 16, 2005

First Posted (ESTIMATE)

November 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-05-0024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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