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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overOtherCDR0000454401
GERCOR-TAUROX, SANOFI-GERCOR-TAUROX, EU-20573, NCT00274885

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

    Philippe Lechat, Study Chair

    Trial Sites

    France

    Grenoble

    CHU de Grenoble - Hopital Michallon

    Christine Rebischung
    Ph: 33-4-7676-5451

    Lille

    Centre Hospital Universitaire Hop Huriez

    Mohamed Hebbar, MD
    Ph: 33-3-2044-5461
    Email: m-hebbar@chru-lille.fr

    Lyon

    Clinique Saint Jean

    Gerard Lledo
    Ph: 33-4-7878-1051

    Paris

    CHU Pitie-Salpetriere

    Jean-Baptiste Meric, MD
    Ph: 33-1-4216-0471
    Email: jeanbaptiste.meric@psl.ap-hop-paris.fr

    Hopital Saint Antoine

    Olivier Rosmorduc, MD, PhD
    Ph: 33-1-4928-2382
    Email: olivier.rosmorduc@sat.aphp.fr

    Hopital Tenon

    Thierry Andre, MD
    Ph: 33-1-6177-0708
    Email: thierry.andre@tnn.ap-hop-paris.fr

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00274885
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.