|Phase IV||Biomarker/Laboratory analysis, Supportive care, Treatment||Active||18 and over||Other||CDR0000454401|
GERCOR-TAUROX, SANOFI-GERCOR-TAUROX, EU-20573, NCT00274885
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
- 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.
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent drug or agent that is potentially neurotoxic
Trial Lead Organizations/Sponsors
GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie
|Philippe Lechat||Study Chair|
|CHU de Grenoble - Hopital Michallon|
|Christine Rebischung||Ph: 33-4-7676-5451|
|Centre Hospital Universitaire Hop Huriez|
|Mohamed Hebbar, MD||Ph: 33-3-2044-5461|
|Clinique Saint Jean|
|Gerard Lledo||Ph: 33-4-7878-1051|
|Jean-Baptiste Meric, MD||Ph: 33-1-4216-0471|
|Hopital Saint Antoine|
|Olivier Rosmorduc, MD, PhD||Ph: 33-1-4928-2382|
|Thierry Andre, MD||Ph: 33-1-6177-0708|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00274885
ClinicalTrials.gov processed this data on October 17, 2013
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