Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017030
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-06-06
Brief Title:
Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of ET-743 Given as a Three Hour Intravenous Infusion in Patients With Advanced andor Metastatic Soft Tissue Sarcoma Previously Treated With Chemotherapy
Status:
COMPLETED
Status Verified Date:
2009-12
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 unresectable advanced or metastatic soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have unresectable advanced or metastatic soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the rate of clinical benefit in terms of the incidence of objective partial and complete response stable disease or minor response of more than 3 months duration in patients with previously treated unresectable advanced or metastatic soft tissue sarcoma treated with ecteinascidin 743 II Determine the progression-free survival overall survival and response duration in patients treated with this drug III Determine the toxicity profile of this drug in these patients IV Determine the pharmacokinetic-pharmacodynamic relationship of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to number of prior cytotoxic therapies for advanced disease 1-2 vs more than 2 Patients receive ecteinascidin 743 IV over 3 hours on day 1 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 36-76 patients 18-38 per stratum will be accrued for this study within 13 months
OUTLINE This is a multicenter study Patients are stratified according to number of prior cytotoxic therapies for advanced disease 1-2 vs more than 2 Patients receive ecteinascidin 743 IV over 3 hours on day 1 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 36-76 patients 18-38 per stratum will be accrued for this study within 13 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 |
|---|---|---|---|
| MSKCC-01018 | None | None | None |
| CDR0000068643 | REGISTRY | None | None |
| NCI-G01-1948 | Registry Identifier | PDQ Physician Data Query | None |