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Trial record 68 of 318 for:    colon cancer | ( Map: Canada )

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255229
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : February 25, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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

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Study Type : Interventional  (Clinical Trial)
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 : December 2002
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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

Primary Outcome Measures :
  1. Reduction in diarrhea. [ Time Frame: Study completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

  • severely abnormal liver and kidney function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255229

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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
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Principal Investigator: Michael Sawyer, MD AHS Cancer Control Alberta

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Responsible Party: AHS Cancer Control Alberta Identifier: NCT00255229     History of Changes
Other Study ID Numbers: GI-05-0024
First Posted: November 18, 2005    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: January 2012
Keywords provided by AHS Cancer Control Alberta:
amino acids
heat shock protein
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents