NCT00255229

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 25, 2016

Status Verified

January 1, 2012

Enrollment Period

7.1 years

First QC Date

November 16, 2005

Last Update Submit

February 24, 2016

Conditions

Metastatic Colorectal Cancer

Keywords

irinotecan5FUamino acidsheat shock protein

Outcome Measures

Primary Outcomes (1)

  • Reduction in diarrhea.

    Study completion

Study Arms (2)

1

ACTIVE COMPARATOR

Irinotecan, 5FU, Glutamine

Drug: Glutamine

2

PLACEBO COMPARATOR

Irinotecan, 5FU, Placebo

Other: Placebo

Interventions

GlutamineDRUG

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

1
PlaceboOTHER

Glutamine placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • metastatic colorectal cancer to be treated with FOLFIAT chemo

You may not qualify if:

  • severely abnormal liver and kidney function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Michael Sawyer, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 18, 2005

Study Start

December 1, 2002

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 25, 2016

Record last verified: 2012-01

Locations

CA(1)