Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00024284|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Childhood Solid Tumor, Protocol Specific||Drug: carboplatin Drug: irinotecan hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors|
|Study Start Date :||June 2001|
|Primary Completion Date :||December 2003|
|Study Completion Date :||December 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024284
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2916|
|United States, Missouri|
|Washington University Medical Center|
|Saint Louis, Missouri, United States, 63105|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Study Chair:||Ashwin Gollerkeri, MD||Bristol-Myers Squibb|