A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Sponsor
- Bristol-Myers Squibb
- Locations
- 7
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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 combining carboplatin and irinotecan in treating children who have refractory solid tumors.
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors. * Determine the safety profile and dose-limiting toxic effects of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine the preliminary anti-tumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of carboplatin and irinotecan. Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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. Patients are followed for at least 30 days. PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified