Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186979
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2005-09-12
Brief Title:
Study of ZD1839 Combined With Irinotecan and Vincristine in Pediatric Patients With Refractory Solid Tumors
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Phase I Study of ZD1839 Iressa in Combination With Irinotecan Camptosar or CPT-11 and Vincristine in Pediatric Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in combination with fixed dose of irinotecan and vincristine in patients with refractory solid tumors
Detailed Description:
Objectives of this study are
To determine the dose-limiting toxicities DLT of the combination of irinotecan and ZD1839 when given on this schedule
To characterize the pharmacokinetics and pharmacodynamics of gefitinib alone and in combination with irinotecan and vincristine
To estimate the maximum tolerated dose MTD of gefitinib in combination with escalating intravenous irinotecan by using selective intestinal decontamination with oral cefixime or cefpodoxime to prevent diarrhea
To estimate the MTD of vincristine MTD in combination with gefitinib and irinotecan
Details of Treatment Interventions
First Cohort
Standard dose escalation starting at ZD1839 150 mgm2day for 21 days in combination with irinotecan 15mgm2day on a daily x 5 for two consecutive week schedule Dose-limiting diarrhea was seen in this cohort ZD scheduled was reduced to 12 days The first dose level 1a consisted of ZD1839 1125mgm2day for 12 days irinotecan 15mgm2day daily x 5 x 2 and was found to be the MTD in this cohort
Second Cohort
Cefixime then added at 4 additional subjects were enrolled at dose level 1c consisting of ZD1839 at 112mgm2day irinotecan 20mgm2day cefixime 8 mgkgday administered once daily beginning on day -1 and continued to day 14
Third Cohort
IrinotecanZD1839VincristineCefixime- Cefixime 8 mgkgday administered once daily beginning on day -1 and continued to day 14 with a maximum dose of 400 mg daily gefitinib 1125 mgm2 orally daily for 12 days and irinotecan at 15 mgm2 daily x 5 x 2 1 mgm2 maximum 2mgdose on days 1 and 8 with escalating dose of VCR as tolerated
To determine the dose-limiting toxicities DLT of the combination of irinotecan and ZD1839 when given on this schedule
To characterize the pharmacokinetics and pharmacodynamics of gefitinib alone and in combination with irinotecan and vincristine
To estimate the maximum tolerated dose MTD of gefitinib in combination with escalating intravenous irinotecan by using selective intestinal decontamination with oral cefixime or cefpodoxime to prevent diarrhea
To estimate the MTD of vincristine MTD in combination with gefitinib and irinotecan
Details of Treatment Interventions
First Cohort
Standard dose escalation starting at ZD1839 150 mgm2day for 21 days in combination with irinotecan 15mgm2day on a daily x 5 for two consecutive week schedule Dose-limiting diarrhea was seen in this cohort ZD scheduled was reduced to 12 days The first dose level 1a consisted of ZD1839 1125mgm2day for 12 days irinotecan 15mgm2day daily x 5 x 2 and was found to be the MTD in this cohort
Second Cohort
Cefixime then added at 4 additional subjects were enrolled at dose level 1c consisting of ZD1839 at 112mgm2day irinotecan 20mgm2day cefixime 8 mgkgday administered once daily beginning on day -1 and continued to day 14
Third Cohort
IrinotecanZD1839VincristineCefixime- Cefixime 8 mgkgday administered once daily beginning on day -1 and continued to day 14 with a maximum dose of 400 mg daily gefitinib 1125 mgm2 orally daily for 12 days and irinotecan at 15 mgm2 daily x 5 x 2 1 mgm2 maximum 2mgdose on days 1 and 8 with escalating dose of VCR as tolerated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None