Ignite Creation Date:
2025-12-18 @ 6:26 AM
Ignite Modification Date:
2025-12-23 @ 8:46 PM
Study NCT ID:
NCT00723255
Status:
None
Last Update Posted:
2019-07-23 00:00:00
First Post:
2008-07-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase II Evaluation of Combination Bevacizumab (NCI-Supplied Agent: NSC #70486) and Temsirolimus (CCI-779, NCI-Supplied Agent, NSC #683864) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status:
None
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:
PRIMARY OBJECTIVES:
I. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial cancer.
II. To determine the nature and degree of toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the duration of PFS and overall survival of patients treated with this regimen.
II. To determine the effects of prognostic factors (i.e., performance status, histological subtype, and grade) in patients treated with this regimen.
TERTIARY OBJECTIVES:
I. To compare the proportion of patients with objective tumor response and PFS at 6 months receiving the combination of bevacizumab and temsirolimus with those for the single agents bevacizumab and temsirolimus using historical controls.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 3 years, for a total of 5 years.
I. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial cancer.
II. To determine the nature and degree of toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the duration of PFS and overall survival of patients treated with this regimen.
II. To determine the effects of prognostic factors (i.e., performance status, histological subtype, and grade) in patients treated with this regimen.
TERTIARY OBJECTIVES:
I. To compare the proportion of patients with objective tumor response and PFS at 6 months receiving the combination of bevacizumab and temsirolimus with those for the single agents bevacizumab and temsirolimus using historical controls.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 3 years, for a total of 5 years.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: