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

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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
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: oxaliplatin Procedure: management of therapy complications Phase 4

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Masking: None (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
Study Start Date : October 2005

Primary Outcome Measures :
  1. Relationship between residual platinum levels in the blood and persistent neurotoxicity

Secondary Outcome Measures :
  1. Pharmacokinetics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of gastrointestinal cancer
  • Receiving or planning to receive 8 months of oxaliplatin-based chemotherapy
  • No pre-existing neuropathy
  • No CNS disease or cerebral metastases


  • WHO 0-1
  • Life expectancy ≥ 12 weeks
  • No biliary or gastro-duodenal obstruction
  • No familial, social, geographical, or psychological condition that would preclude study treatment


  • See Disease Characteristics
  • No other concurrent drug or agent that is potentially neurotoxic

Information from the National Library of Medicine

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

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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    m-hebbar@chru-lille.fr   
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    olivier.rosmorduc@sat.aphp.fr   
CHU Pitie-Salpetriere Recruiting
Paris, France, 75651
Contact: Jean-Baptiste Meric, MD    33-1-4216-0471    jeanbaptiste.meric@psl.ap-hop-paris.fr   
Hopital Tenon Recruiting
Paris, France, 75970
Contact: Thierry Andre, MD    33-1-6177-0708    thierry.andre@tnn.ap-hop-paris.fr   
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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Study Chair: Philippe Lechat CHU Pitie-Salpetriere
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ClinicalTrials.gov Identifier: NCT00274885    
Other Study ID Numbers: CDR0000454401
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: December 5, 2011
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
carcinoma of the appendix
recurrent anal cancer
stage I anal cancer
stage II anal cancer
stage IIIA anal cancer
stage IIIB anal cancer
stage IV anal cancer
localized extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
unresectable extrahepatic bile duct cancer
localized gallbladder cancer
recurrent gallbladder cancer
unresectable gallbladder cancer
recurrent gastric cancer
stage IV gastric cancer
recurrent colon cancer
recurrent rectal cancer
recurrent esophageal cancer
localized gastrointestinal carcinoid tumor
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
gastrointestinal stromal tumor
advanced adult primary liver cancer
localized resectable adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
recurrent pancreatic cancer
stage I pancreatic cancer
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Neurotoxicity Syndromes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Nervous System Diseases
Chemically-Induced Disorders
Antineoplastic Agents