A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
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.
Interventional
Primary Purpose: Treatment
Ashwin Gollerkeri, MD
Study Chair
Bristol-Myers Squibb
United States: Federal Government
CDR0000068908
NCT00024284
June 2001
December 2003
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Washington University Medical Center | Saint Louis, Missouri 63105 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |