Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020930
Status:
COMPLETED
Last Update Posted:
2009-12-04
First Post:
2001-07-11
Brief Title:
Cetuximab in Treating Patients With Stage IV Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of an Anti-Epidermal Growth Factor Receptor EGFR Antibody Cetuximab in Patients With Irinotecan-Refractory Stage IV Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-12
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 locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of cetuximab in treating patients who have stage IV colorectal cancer that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of cetuximab in treating patients who have stage IV colorectal cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the response rate of patients with irinotecan-refractory stage IV colorectal cancer when treated with cetuximab II Determine the safety and toxic effects of this drug in these patients III Determine the time to progression of patients treated with this drug
OUTLINE This is a multicenter study Patients receive cetuximab IV over 1-2 hours weekly for 6 weeks Treatment repeats in the absence of disease progression or unacceptable toxicity Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 4 months
OUTLINE This is a multicenter study Patients receive cetuximab IV over 1-2 hours weekly for 6 weeks Treatment repeats in the absence of disease progression or unacceptable toxicity Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 4 months
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 |
|---|---|---|---|
| NCI-G01-1970 | None | None | None |
| MSKCC-01034 | None | None | None |
| IMCL-CP02-0141 | None | None | None |