Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

AHS Cancer Control Alberta

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Glutamine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00255229

GI-05-0024

Details and patient eligibility

About

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%.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion criteria

• severely abnormal liver and kidney function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Irinotecan, 5FU, Glutamine

Treatment:

Drug: Glutamine

2

Placebo Comparator group

Description:

Irinotecan, 5FU, Placebo

Treatment:

Other: Placebo