Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027508
Status:
TERMINATED
Last Update Posted:
2015-02-24
First Post:
2001-12-07
Brief Title:
Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
Sponsor:
PharmaMar
Organization:
PharmaMar
Study Overview
Official Title:
Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrolment halted prematurely and not resumed 2 patients enrolled No data was obtained
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 malignant mesothelioma that cannot be removed by surgery
PURPOSE Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have malignant mesothelioma that cannot be removed by surgery
Detailed Description:
OBJECTIVES I Determine partial and complete response rates in patients with unresectable malignant mesothelioma treated with ecteinascidin 743 II Determine the toxicity profile of this drug in these patients III Determine the pharmacokineticpharmacodynamic relationships of this drug in these patients IV Determine the duration of response time to disease progression 6-month progression-free survival time to treatment failure and overall survival of patients treated with this drug V Assess the quality of life of these patients treated with this drug
OUTLINE This is a multicenter study Patients receive ecteinascidin 743 IV over 3 hours on day 1 Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 2 additional courses after achieving CR Quality of life is assessed at baseline and at the beginning of each course of therapy Patients are followed every 3 months
PROJECTED ACCRUAL A total of 20-36 patients will be accrued for this study within 12-24 months
OUTLINE This is a multicenter study Patients receive ecteinascidin 743 IV over 3 hours on day 1 Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 2 additional courses after achieving CR Quality of life is assessed at baseline and at the beginning of each course of therapy Patients are followed every 3 months
PROJECTED ACCRUAL A total of 20-36 patients will be accrued for this study within 12-24 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 |
|---|---|---|---|
| CDR0000069034 | REGISTRY | None | None |
| PMAR-ET-B-020-99 | None | None | None |
| NCI-G01-2026 | Registry Identifier | PDQ Physician Data Query | None |