Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00274885|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : January 11, 2006
Last Update Posted : December 5, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: oxaliplatin Procedure: management of therapy complications||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
- Relationship between residual platinum levels in the blood and persistent neurotoxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274885
|CHU de Grenoble - Hopital Michallon||Recruiting|
|Grenoble, France, 38043|
|Contact: Christine Rebischung 33-4-7676-5451|
|Centre Hospital Universitaire Hop Huriez||Recruiting|
|Lille, France, 59037|
|Contact: Mohamed Hebbar, MD 33-3-2044-5461 firstname.lastname@example.org|
|Clinique Saint Jean||Recruiting|
|Lyon, France, 69008|
|Contact: Gerard Lledo 33-4-7878-1051|
|Hopital Saint Antoine||Recruiting|
|Paris, France, 75571|
|Contact: Olivier Rosmorduc, MD, PhD 33-1-4928-2382 email@example.com|
|Paris, France, 75651|
|Contact: Jean-Baptiste Meric, MD 33-1-4216-0471 firstname.lastname@example.org|
|Paris, France, 75970|
|Contact: Thierry Andre, MD 33-1-6177-0708 email@example.com|
|Study Chair:||Philippe Lechat||CHU Pitie-Salpetriere|