NCT00274885

Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer

Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably. PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.

Detailed description

OBJECTIVES: Primary * Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer. Secondary * Determine the pharmacokinetics of oxaliplatin in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 2-3 weeks in the absence of disease progression or unacceptable toxicity. Neurological function and platinum levels in the blood are assessed at baseline, after each course of oxaliplatin, and at the end of study treatment. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin
PROCEDURE	management of therapy complications

Timeline

• Start date: 2005-10-01
• First posted: 2006-01-11
• Last updated: 2011-12-05

Locations

6 sites across 1 country: France