Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369655
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2006-08-24
Brief Title:
VEGF Trap in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of VEGF Trap in Patients With Metastatic Breast Cancer Previously Treated With Anthracycline andor Taxane
Status:
COMPLETED
Status Verified Date:
2013-11
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 VEGF Trap works in treating patients with metastatic breast cancer VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Assess the antitumor activity of VEGF Trap in terms of tumor response rate in patients with metastatic breast cancer who have received 2 prior chemotherapy regimens for metastatic disease including a taxane andor anthracycline
II Assess the 6-month progression-free survival rate in patients treated with VEGF Trap
SECONDARY OBJECTIVES
I Describe the adverse event profile grade using the NCI CTCAE version 30 of VEGF Trap in these patients
II Describe the progression-free survival times in patients treated with VEGF Trap
III Describe the overall survival of patients treated with VEGF Trap IV Describe the duration of response in patients treated with VEGF Trap
OUTLINE This is a multicenter study
Patients receive VEGF Trap IV over 1 hour on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3-6 months for up to 5 years
I Assess the antitumor activity of VEGF Trap in terms of tumor response rate in patients with metastatic breast cancer who have received 2 prior chemotherapy regimens for metastatic disease including a taxane andor anthracycline
II Assess the 6-month progression-free survival rate in patients treated with VEGF Trap
SECONDARY OBJECTIVES
I Describe the adverse event profile grade using the NCI CTCAE version 30 of VEGF Trap in these patients
II Describe the progression-free survival times in patients treated with VEGF Trap
III Describe the overall survival of patients treated with VEGF Trap IV Describe the duration of response in patients treated with VEGF Trap
OUTLINE This is a multicenter study
Patients receive VEGF Trap IV over 1 hour on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3-6 months for up to 5 years
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 |
|---|---|---|---|
| CDR0000491314 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA025224 |
| NCCTG-N0537 | None | None | None |
| U10CA025224 | NIH | None | None |