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