Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055809
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2003-03-06
Brief Title:
Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b PEG Intron In Patients With Metastatic Or Unresectable Carcinoid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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 randomized phase II trial is to see if combining bevacizumab with PEG-interferon alfa-2b works in treating patients who have metastatic or unresectable carcinoid tumors Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor Combining bevacizumab with PEG-interferon alfa-2b may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the progression-free survival rate in patients with metastatic or unresectable carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b
II Determine the tumor response rate complete and partial in patients treated with this regimen
III Determine the biochemical response rate of patients treated with this regimen
IV Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients
OUTLINE This is a randomized study Patients are treated in 2 stages
Stage I Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV on day 1
Arm II Patients receive PEG-interferon alfa-2b subcutaneously SC on days 1 8 and 15
In both arms courses repeat every 3 weeks Patients with progressive disease at 9 weeks proceed to stage II All other patients proceed to stage II after 18 weeks on stage I
Stage II Patients receive bevacizumab IV on day 1 and PEG-interferon alfa-2b SC once weekly Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR and remain in CR for 2 additional courses come off study Patients are followed for survival
I Determine the progression-free survival rate in patients with metastatic or unresectable carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b
II Determine the tumor response rate complete and partial in patients treated with this regimen
III Determine the biochemical response rate of patients treated with this regimen
IV Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients
OUTLINE This is a randomized study Patients are treated in 2 stages
Stage I Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV on day 1
Arm II Patients receive PEG-interferon alfa-2b subcutaneously SC on days 1 8 and 15
In both arms courses repeat every 3 weeks Patients with progressive disease at 9 weeks proceed to stage II All other patients proceed to stage II after 18 weeks on stage I
Stage II Patients receive bevacizumab IV on day 1 and PEG-interferon alfa-2b SC once weekly Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR and remain in CR for 2 additional courses come off study Patients are followed for survival
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 |
|---|---|---|---|
| CDR0000271225 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62202 |
| MDA-ID-02063 | None | None | None |
| N01CM62202 | NIH | None | None |