Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041236
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2002-07-08
Brief Title:
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group
Status:
COMPLETED
Status Verified Date:
2012-07
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 advanced soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma
Detailed Description:
OBJECTIVES
Determine the anticancer activity of exatecan mesylate in terms of objective response and duration of response in patients with advanced soft tissue sarcoma
Determine the safety of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to histological diagnosis leiomyosarcoma vs other histologies
Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks until disease progression After disease progression patients are followed every 12 weeks for survival
PROJECTED ACCRUAL A total of 32-50 patients 16-25 per stratum will be accrued for this study
Determine the anticancer activity of exatecan mesylate in terms of objective response and duration of response in patients with advanced soft tissue sarcoma
Determine the safety of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to histological diagnosis leiomyosarcoma vs other histologies
Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks until disease progression After disease progression patients are followed every 12 weeks for survival
PROJECTED ACCRUAL A total of 32-50 patients 16-25 per stratum 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 |
|---|---|---|---|
| EORTC-62006 | None | None | None |