Relationship Between Platinum Levels in the Blood and Neurotoxicity in Patients Who Are Receiving Oxaliplatin for Gastrointestinal Cancer
Basic Trial Information
|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 Contact Information
Trial Lead Organizations/Sponsors
GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie
CHU de Grenoble - Hopital Michallon
Centre Hospital Universitaire Hop Huriez
Mohamed Hebbar, MD
Clinique Saint Jean
Jean-Baptiste Meric, MD
Hopital Saint Antoine
Olivier Rosmorduc, MD, PhD
Thierry Andre, MD
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.