Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040781
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2002-07-08
Brief Title:
Gefitinib in Treating Children With Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of ZD1839 Iressa TM An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor In Children With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of gefitinib in treating children who have refractory solid tumors Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of gefitinib in children with refractory solid tumors
II Determine the dose-limiting toxicity of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Determine preliminarily the antitumor activity of this drug in these patients
V Correlate the pharmacogenetic polymorphisms of this drug with pharmacokinetics and pharmacodynamics in these patients
OUTLINE This is a dose-escalation multicenter study If myelosuppression is found to be the dose-limiting toxicity patients are stratified according to prior therapy more than 2 multiagent chemotherapy regimens or radiotherapy to more than 20 of the bone marrow or stem cell transplantation with or without total body irradiation vs more than 2 single-agent phase I or phase II agents and extent of disease bone marrow involvement vs meeting none of the stratum I criteria
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 3-45 patients will be accrued for this study
I Determine the maximum tolerated dose of gefitinib in children with refractory solid tumors
II Determine the dose-limiting toxicity of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Determine preliminarily the antitumor activity of this drug in these patients
V Correlate the pharmacogenetic polymorphisms of this drug with pharmacokinetics and pharmacodynamics in these patients
OUTLINE This is a dose-escalation multicenter study If myelosuppression is found to be the dose-limiting toxicity patients are stratified according to prior therapy more than 2 multiagent chemotherapy regimens or radiotherapy to more than 20 of the bone marrow or stem cell transplantation with or without total body irradiation vs more than 2 single-agent phase I or phase II agents and extent of disease bone marrow involvement vs meeting none of the stratum I criteria
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 3-45 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069406 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0016 | None | None | None |
| U01CA097452 | NIH | None | None |