Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390234
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2006-10-18
Brief Title:
Ziv-aflibercept in Treating Patients With Locally Advanced Unresectable or Metastatic Gynecologic Soft Tissue Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of VEGF-Trap in Recurrent or Metastatic Gynecologic Soft-Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2013-05
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:
This phase II trial is studying how well ziv-aflibercept works in treating patients with locally advanced unresectable or metastatic gynecologic soft tissue sarcoma Ziv-aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap ziv-aflibercept
II To assess the incidence of disease stabilization as measured by 6-month progression-free survival in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap
SECONDARY OBJECTIVES
I To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap
As of 24 October 2012 overall survival follow-up is to be discontinued for the one remaining patient on long term follow-up who has been off protocol therapy for at least 3 years Time to progression and median survival times have been based on the currently available data
II To assess the toxicity associated with VEGF-Trap in patients with recurrent or metastatic gynecologic soft-tissue sarcoma
III To characterize the population pharmacokinetics of VEGF-Trap and to explore for demographic and clinical covariates
OUTLINE This is an open-label multicenter study
Patients are stratified according to histology uterine leiomyosarcoma vs malignant mixed mullerian tumorcarcinosarcoma Patients receive ziv-aflibercept over 1 hour on day 1 Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity Patients undergo blood collection at baseline every 8 weeks during treatment and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay ELISA
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
I To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap ziv-aflibercept
II To assess the incidence of disease stabilization as measured by 6-month progression-free survival in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap
SECONDARY OBJECTIVES
I To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap
As of 24 October 2012 overall survival follow-up is to be discontinued for the one remaining patient on long term follow-up who has been off protocol therapy for at least 3 years Time to progression and median survival times have been based on the currently available data
II To assess the toxicity associated with VEGF-Trap in patients with recurrent or metastatic gynecologic soft-tissue sarcoma
III To characterize the population pharmacokinetics of VEGF-Trap and to explore for demographic and clinical covariates
OUTLINE This is an open-label multicenter study
Patients are stratified according to histology uterine leiomyosarcoma vs malignant mixed mullerian tumorcarcinosarcoma Patients receive ziv-aflibercept over 1 hour on day 1 Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity Patients undergo blood collection at baseline every 8 weeks during treatment and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay ELISA
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| N01CM62201 | NIH | N01CM62209 | httpsreporternihgovquickSearchN01CM62201 |
| PHL-051 | OTHER_GRANT | None | None |
| CDR0000508798 | OTHER_GRANT | None | None |
| N01CM62209 | NIH | None | None |
| N01CM62203 | NIH | None | None |