Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462826
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2007-04-18
Brief Title:
VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of VEGF-Trap AFLIBERCEPT NSC 724770 NCI-Supplied Agent in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-07
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 the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial cancer in terms of the frequency of patients who have progression-free survival for at least 6 months after initiating therapy or have objective tumor response
II Determine the toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the duration of progression-free survival and overall survival of patients treated with this drug
OUTLINE
Patients receive VEGF Trap IV over 1 hour on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
I Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial cancer in terms of the frequency of patients who have progression-free survival for at least 6 months after initiating therapy or have objective tumor response
II Determine the toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the duration of progression-free survival and overall survival of patients treated with this drug
OUTLINE
Patients receive VEGF Trap IV over 1 hour on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00597 | REGISTRY | None | None |
| CDR0000540237 | None | None | None |
| GOG-0229F | OTHER | None | None |
| GOG-0229F | OTHER | None | None |