Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055952
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2003-03-06
Brief Title:
Exatecan Mesylate in Treating Patients With Ewings Sarcoma Primitive Neuroectodermal Tumor or Desmoplastic Small Round Cell Tumor
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase II Study Of Intravenous DX-8951f EXATECAN MESYLATE Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewings Sarcoma ES Primitive Neuroectodermal Tumor PNET Or Desmoplastic Small Round Cell Tumor DSRCT
Status:
COMPLETED
Status Verified Date:
2012-05
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewings sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor
PURPOSE Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewings sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with Ewings sarcoma primitive neuroectodermal tumor or desmoplastic small round cell tumor treated with exatecan mesylate
Determine the time to tumor progression in patients treated with this drug
Determine median survival and 6- and 12-month survival of patients treated with this drug
Determine the pain response in patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is an open-label non-randomized multicenter study Patients are stratified according to disease relapsed or refractory localized or metastatic Ewings sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor
Patients receive exatecan mesylate IV over 30 minutes on days 1-5 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses or 6 courses beyond maximal response whichever is longer
Patients are followed every 3 months for 1 year after withdrawal from study
PROJECTED ACCRUAL A total of 13-27 patients will be accrued for stratum I within 12 months A total of 9-17 patients will be accrued for stratum II within 15 months
Determine the objective response rate in patients with Ewings sarcoma primitive neuroectodermal tumor or desmoplastic small round cell tumor treated with exatecan mesylate
Determine the time to tumor progression in patients treated with this drug
Determine median survival and 6- and 12-month survival of patients treated with this drug
Determine the pain response in patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is an open-label non-randomized multicenter study Patients are stratified according to disease relapsed or refractory localized or metastatic Ewings sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor
Patients receive exatecan mesylate IV over 30 minutes on days 1-5 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses or 6 courses beyond maximal response whichever is longer
Patients are followed every 3 months for 1 year after withdrawal from study
PROJECTED ACCRUAL A total of 13-27 patients will be accrued for stratum I within 12 months A total of 9-17 patients will be accrued for stratum II within 15 months
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 |
|---|---|---|---|
| SJCRH-DXEWS | None | None | None |
| DAIICHI-8951A-PRT034 | None | None | None |