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Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

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ClinicalTrials.gov Identifier: NCT00255229
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : February 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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  (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
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

  • severely abnormal liver and kidney function
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00255229


Locations
Canada, Alberta
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
More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov 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:
irinotecan
5FU
amino acids
heat shock protein

Additional relevant MeSH terms:
Colorectal Neoplasms
Diarrhea
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action