A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
- 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
- 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
Primary Purpose: Treatment
Ashwin Gollerkeri, MD
United States: Federal Government
|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|