A Phase I Study of Oxaliplatin in Children With Solid Tumors
- Determine the maximum tolerated dose of oxaliplatin in children with advanced solid
- Determine the toxic effects of this drug in these patients.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the relationship between pharmacokinetic parameters and toxicity of this regimen
and response in these patients.
- Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR
on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD for dose levels 1-4 is determined, an additional cohort of 3-6 patients is
accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses).
PROJECTED ACCRUAL: Approximately 6-20 patients will be accrued for this study within 1-3.3
Primary Purpose: Treatment
Sheri L. Spunt, MD
St. Jude Children's Research Hospital
United States: Federal Government
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|