Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039273
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2002-06-06
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma
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:
RATIONALE Monoclonal antibodies 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 monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF
Determine the additional measures of clinical efficacy of this drug in terms of progression-free survival overall survival and time to treatment failure in these patients
Determine the safety of this drug in these patients
OUTLINE This is a multicenter study
Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8 Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 20-100 patients will be accrued for this study
Determine the response rate of patients with metastatic colorectal cancer treated with monoclonal antibody ABX-EGF
Determine the additional measures of clinical efficacy of this drug in terms of progression-free survival overall survival and time to treatment failure in these patients
Determine the safety of this drug in these patients
OUTLINE This is a multicenter study
Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8 Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks every 3 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 20-100 patients will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0112063 | None | None | None |
| NCI-G02-2073 | None | None | None |
| IMMUNEX-054-0005 | None | None | None |