Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
Recruitment status was: Recruiting
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.
Procedure: management of therapy complications
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Relationship between residual platinum levels in the blood and persistent neurotoxicity [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
- Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274885
|CHU de Grenoble - Hopital Michallon|
|Grenoble, France, 38043|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59037|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75651|
|Paris, France, 75970|
|Study Chair:||Philippe Lechat||CHU Pitie-Salpetriere|