Cancer Clinical Trial
Official title:
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.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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