Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054574
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-02-05
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis
Status:
COMPLETED
Status Verified Date:
2012-08
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 ABX-EGF 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 ABX-EGF in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of ABX-EGF in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine the clinical effect of monoclonal antibody ABX-EGF determined by the PSA response in patients with hormone-resistant prostate cancer with rising PSA values without metastasis
Determine the pharmacokinetics and safety profile including immunogenicity of this drug in these patients
Determine the overall survival of patients treated with this drug
Determine the time to disease progression and time to PSA progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly Treatment continues every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL Approximately 30-50 patients will be accrued for this study
Determine the clinical effect of monoclonal antibody ABX-EGF determined by the PSA response in patients with hormone-resistant prostate cancer with rising PSA values without metastasis
Determine the pharmacokinetics and safety profile including immunogenicity of this drug in these patients
Determine the overall survival of patients treated with this drug
Determine the time to disease progression and time to PSA progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly Treatment continues every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL Approximately 30-50 patients will be accrued for this study
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 |
|---|---|---|---|
| ABX-0301 | None | None | None |
| UCLA-0206074 | None | None | None |