Back to results

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Primary Purpose

Metastatic Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Glutamine

Placebo

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring irinotecan, 5FU, amino acids, heat shock protein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: metastatic colorectal cancer to be treated with FOLFIAT chemo Exclusion Criteria: severely abnormal liver and kidney function

Sites / Locations

Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Irinotecan, 5FU, Glutamine

Irinotecan, 5FU, Placebo

Outcomes

Primary Outcome Measures

Reduction in diarrhea.

Secondary Outcome Measures

Full Information

NCT ID

NCT00255229

First Posted

November 16, 2005

Last Updated

February 24, 2016

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00255229

Brief Title

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Official Title

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

irinotecan, 5FU, amino acids, heat shock protein

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Irinotecan, 5FU, Glutamine

Arm Title

Arm Type

Placebo Comparator

Arm Description

Irinotecan, 5FU, Placebo

Intervention Type

Drug

Intervention Name(s)

Glutamine

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Glutamine placebo

Primary Outcome Measure Information:

Title

Reduction in diarrhea.

Time Frame

Study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: metastatic colorectal cancer to be treated with FOLFIAT chemo Exclusion Criteria: severely abnormal liver and kidney function

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Sawyer, MD

Organizational Affiliation

AHS Cancer Control Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

We'll reach out to this number within 24 hrs