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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274885
First received: January 10, 2006
Last updated: December 2, 2011
Last verified: May 2007
History of Changes

January 10, 2006
December 2, 2011
October 2005
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Relationship between residual platinum levels in the blood and persistent neurotoxicity [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00274885 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Designated as safety issue: No ]
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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

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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • Drug: oxaliplatin
  • Procedure: management of therapy complications
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
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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
Both
18 Years and older
No
Not Provided
France
 
NCT00274885
CDR0000454401, GERCOR-TAUROX, SANOFI-GERCOR-TAUROX, EU-20573
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Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
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Study Chair: Philippe Lechat CHU Pitie-Salpetriere
National Cancer Institute (NCI)
May 2007

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