Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379145
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2006-09-19
Brief Title:
Trabectedin in Treating Patients With Advanced Persistent or Recurrent Leiomyosarcoma of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Trabectedin Yondelis R279741 in the Treatment of Advanced Persistent or Recurrent Uterine Leiomyosarcomas
Status:
COMPLETED
Status Verified Date:
2015-05
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 such as trabectedin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well trabectedin works in treating patients with advanced persistent or recurrent leiomyosarcoma of the uterus
PURPOSE This phase II trial is studying how well trabectedin works in treating patients with advanced persistent or recurrent leiomyosarcoma of the uterus
Detailed Description:
OBJECTIVES
Determine the antitumor activity of trabectedin as measured by frequency and duration of objective response in patients with advanced persistent or recurrent uterine leiomyosarcoma
Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a nonrandomized multicenter study
Patients receive trabectedin IV continuously over 24 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve a confirmed complete response may receive at least 2 additional courses
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Determine the antitumor activity of trabectedin as measured by frequency and duration of objective response in patients with advanced persistent or recurrent uterine leiomyosarcoma
Determine the nature and degree of toxicity of this drug in these patients
OUTLINE This is a nonrandomized multicenter study
Patients receive trabectedin IV continuously over 24 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve a confirmed complete response may receive at least 2 additional courses
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 43 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 |
|---|---|---|---|
| CDR0000502192 | OTHER | None | None |
| NCI-2009-00573 | OTHER | NCI | None |