Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Sponsor

AHS Cancer Control Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT00255229

Collaborator

Cross Cancer Institute (Other)

130

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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%.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: Glutamine Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Study Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction in diarrhea. [Study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

severely abnormal liver and kidney function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2

Sponsors and Collaborators

AHS Cancer Control Alberta
Cross Cancer Institute

Investigators

Principal Investigator: Michael Sawyer, MD, AHS Cancer Control Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AHS Cancer Control Alberta

ClinicalTrials.gov Identifier:

NCT00255229

Other Study ID Numbers:

GI-05-0024

First Posted:

Nov 18, 2005

Last Update Posted:

Feb 25, 2016

Last Verified:

Jan 1, 2012

Keywords provided by AHS Cancer Control Alberta

Additional relevant MeSH terms:

Diarrhea

Study Results

No Results Posted as of Feb 25, 2016