NCT01157039

A Trial of Glutamine to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin

A Phase II Trial of Glutamin to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that glutamine significantly reduces the incidence and severity of peripheral neuropathy in patients receiving oxaliplatin for metastatic colorectal cancer, decreases the need for dose reduction of oxaliplatin, and it does not impair oxaliplatin efficacy or pharmacokinetics.

Detailed description

This is a phase II , open-label, non randomized study of oral glutamine administration to evaluate oxaliplatin pharmacokinetics, and to prevent oxaliplatin neurotoxicity in patients with metastatic colorectal cancer.

Conditions

• Colorectal Carcinoma
• Neoplasms, Colorectal
• Colorectal Cancer
• Colorectal Tumors
• Metastasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glutamine	Glutamine- During the first cycle of oxaliplatin based combination therapy (mFOLFOX 6 or XELOX) no patient will receive glutamine. At cycle 2, patients will be randomized to receive for 6 days either : Glutamine 30g/day during cycle 2 and glutamine 40g/day during cycle 3 (ARM A) or glutamine 40g/day at cycle 2 and glutamine 30g/day at cycle 3 (Arm B).

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• First posted: 2010-07-05
• Last updated: 2016-02-24