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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE January 10, 2006
First Posted Date  ICMJE January 11, 2006
Last Update Posted Date December 5, 2011
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2006)
Relationship between residual platinum levels in the blood and persistent neurotoxicity
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00274885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2006)
Pharmacokinetics
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: oxaliplatin
  • Procedure: management of therapy complications
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
58
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No other concurrent drug or agent that is potentially neurotoxic
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00274885
Other Study ID Numbers  ICMJE CDR0000454401
GERCOR-TAUROX
SANOFI-GERCOR-TAUROX
EU-20573
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Philippe Lechat CHU Pitie-Salpetriere
PRS Account National Cancer Institute (NCI)
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP