NCT00005844

Oxaliplatin in Treating Children With Advanced Solid Tumors

A Phase I Study of Oxaliplatin in Children With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors. * 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 years.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	oxaliplatin

Timeline

• Start date: 2000-04-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2003-01-27
• Last updated: 2012-10-23

Locations

1 site across 1 country: United States