Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077454
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-02-10
Brief Title:
Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Single Agent OSI-774 Tarceva NSC 718781 IND 63383 Followed by OSI-774 With Temozolomide for Patients With Selected RecurrentRefractory Solid Tumors Including Brain Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase I trial is studying the side effects and best dose of erlotinib when given with temozolomide in treating young patients with recurrent or refractory solid tumors Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die Giving erlotinib with temozolomide may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of erlotinib in children with recurrent or refractory solid tumors
II Determine the dose-limiting toxic effects of this drug alone and with temozolomide in these patients
III Determine the tolerability of this regimen in these patients IV Determine the pharmacokinetics of this regimen in these patients
SECONDARY OBJECTIVES
I Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is a 2-part multicenter dose-escalation study of erlotinib Patients are stratified according to pretreatment heavily pretreated received more than 2 prior multiagent myelosuppressive chemotherapy regimens OR received prior craniospinal or pelvic radiotherapy or bone marrow transplantation OR has bone marrow involvement vs less heavily pretreatedPart 1
Patients receive oral erlotinib once daily on days 1-28 Beginning with course 2 patients also receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib during course 1 only 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
Part 2 Patients receive erlotinib at the MTD and temozolomide as in part 1
PROJECTED ACCRUAL A total of 9-45 patients 9-24 for part 1 and up to 21 for part 2 will be accrued for this study
I Determine the maximum tolerated dose of erlotinib in children with recurrent or refractory solid tumors
II Determine the dose-limiting toxic effects of this drug alone and with temozolomide in these patients
III Determine the tolerability of this regimen in these patients IV Determine the pharmacokinetics of this regimen in these patients
SECONDARY OBJECTIVES
I Determine preliminarily the antitumor activity of this regimen in these patients
OUTLINE This is a 2-part multicenter dose-escalation study of erlotinib Patients are stratified according to pretreatment heavily pretreated received more than 2 prior multiagent myelosuppressive chemotherapy regimens OR received prior craniospinal or pelvic radiotherapy or bone marrow transplantation OR has bone marrow involvement vs less heavily pretreatedPart 1
Patients receive oral erlotinib once daily on days 1-28 Beginning with course 2 patients also receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib during course 1 only 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
Part 2 Patients receive erlotinib at the MTD and temozolomide as in part 1
PROJECTED ACCRUAL A total of 9-45 patients 9-24 for part 1 and up to 21 for part 2 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 |
|---|---|---|---|
| ADVL0214 | None | None | None |
| CDR0000350336 | None | None | None |
| COG-ADVL0214 | None | None | None |
| NCI-04-C-0256 | None | None | None |
| U01CA097452 | NIH | None | httpsreporternihgovquickSearchU01CA097452 |