Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003939
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Ecteinascidin 743 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:
Phase II Study on ET-743 in Advanced Soft Tissue Sarcomas of the Adult
Status:
COMPLETED
Status Verified Date:
2012-09
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 ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas II Determine the duration of response in these patients III Determine the acute side effects in these patients
OUTLINE This is a multicenter study Patients receive ecteinascidin 743 ET-743 IV over 24 hours every 3 weeks Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression
PROJECTED ACCRUAL Approximately 28-44 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive ecteinascidin 743 ET-743 IV over 24 hours every 3 weeks Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression
PROJECTED ACCRUAL Approximately 28-44 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 |
|---|---|---|---|
| EORTC-62982 | None | None | None |