Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079066
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-03-08
Brief Title:
Cetuximab Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Randomized Study of Cetuximab Erbitux C225 and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor EGFR-Positive Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-04
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 Monoclonal antibodies such as cetuximab can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Best supportive care is the use of drugs and other treatments to improve the quality of life of patients Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer
PURPOSE This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer
PURPOSE This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone
Secondary
Compare the time to disease progression in patients treated with these regimens
Compare the objective response rate in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the health utilities of patients treated with these regimens
Conduct a comparative economic evaluation in patients treated with these regimens
Determine the safety profile of cetuximab in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center and ECOG performance status 0 or 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive an initial loading dose of cetuximab IV over 120 minutes on day 1 Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly Patients also receive best supportive care defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible
Arm II Patients receive best supportive care as in arm I In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then at 4 8 16 and 24 weeks or until deterioration to ECOG PS 4 or hospitalization for end-of-life care
Patients are followed every 4 weeks
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study within 20 months
Primary
Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone
Secondary
Compare the time to disease progression in patients treated with these regimens
Compare the objective response rate in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the health utilities of patients treated with these regimens
Conduct a comparative economic evaluation in patients treated with these regimens
Determine the safety profile of cetuximab in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center and ECOG performance status 0 or 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive an initial loading dose of cetuximab IV over 120 minutes on day 1 Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly Patients also receive best supportive care defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible
Arm II Patients receive best supportive care as in arm I In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then at 4 8 16 and 24 weeks or until deterioration to ECOG PS 4 or hospitalization for end-of-life care
Patients are followed every 4 weeks
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study within 20 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000353486 | OTHER | PDQ | None |
| CAN-NCIC-CO17 | OTHER | None | None |
| AGITG-CAN-NCIC-CO17 | OTHER | None | None |
| BMS-CA225-025 | OTHER | None | None |
| IMCL-CAN-NCIC-CO17 | OTHER | None | None |