Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072046
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2003-11-04
Brief Title:
Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma Kidney Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Biological therapies such as interferon alfa-2b may interfere with the growth of tumor cells Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma kidney cancer
PURPOSE This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma
PURPOSE This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab
Secondary
Compare the time to disease progression and objective response rates in patients treated with these regimens
Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior nephrectomy yes vs no and number of risk factors for disease progression 0 vs 1-2 vs 3 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive interferon alfa-2b subcutaneously SC three times a week
Arm II Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then annually for up to 10 years after study entry
PROJECTED ACCRUAL A total of 700 patients 350 per treatment arm will be accrued for this study within 3 years
Primary
Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab
Secondary
Compare the time to disease progression and objective response rates in patients treated with these regimens
Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior nephrectomy yes vs no and number of risk factors for disease progression 0 vs 1-2 vs 3 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive interferon alfa-2b subcutaneously SC three times a week
Arm II Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then annually for up to 10 years after study entry
PROJECTED ACCRUAL A total of 700 patients 350 per treatment arm will be accrued for this study within 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CAN-NCIC-REC1 | None | None | None |
| CDR0000335292 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |