Metastatic Colorectal Cancer
Conditions
Keywords
irinotecan, 5FU, amino acids, heat shock protein
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%.
Interventions
DRUGGlutamine
Glutamine 10 g four times daily starting two days before treatment for six days in total
OTHERPlacebo
Glutamine placebo
Sponsors
Cross Cancer Institute
AHS Cancer Control Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* metastatic colorectal cancer to be treated with FOLFIAT chemo
Exclusion criteria
* severely abnormal liver and kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in diarrhea. | Study completion |
Countries
Canada
Outcome results
None listed