BACKGROUND: Oxaliplatin, a platinum compound, has been commonly used around the 
world for treating advanced colorectal cancer. The generally recommended dose 
and schedule of oxaliplatin monotherapy is 130 mg/m(2) every 3 weeks. This trial 
was conducted to evaluate the safety and pharmacokinetics of oxaliplatin 
monotherapy in Japanese patients with solid tumors.
METHODS: Oxaliplatin was administered as a 2-h intravenous infusion every 3 
weeks at a dose of 90 and 130 mg/m(2). Blood was collected to determine the 
total platinum and the ultrafiltrate platinum concentrations in plasma in all 
cycles.
RESULTS: Nine patients were enrolled; three were given oxaliplatin monotherapy 
at 90 mg/m(2) and six received 130 mg/m(2). All tumors were colorectal cancer. 
The major adverse reactions included myelosuppressive, neurological and 
gastrointestinal toxicities, although most were grades 1 and 2 at both dose 
levels. Peripheral sensory neuropathy of without movement disturbance (grade 1 
or 2) was observed in all patients at both dose levels. The 130 mg/m(2) dose 
level was not found to be the maximum tolerated dose, but was judged to be the 
recommended dose. No objective responses were seen and five cases of no change 
were observed. A bi-exponential open model best described the disappearance of 
platinum in the plasma, and a tri-exponential open model best described the 
disappearance of ultrafilterable platinum in the plasma at both dose levels. No 
racial difference was suggested in the pharmacokinetics of oxaliplatin.
CONCLUSIONS: The oxaliplatin monotherapy dose schedule of 130 mg/m(2) every 3 
weeks, recommended worldwide, is acceptable for Japanese patients.