Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003740
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Trastuzumab in Treating Patients With Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Herceptin Recombinant Humanized Anti-p185HER2 Monoclonal Antibody for the Treatment of Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 trastuzumab in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of trastuzumab in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Assess the activity of trastuzumab Herceptin in patients with progressive androgen dependent and independent prostate cancer II Study HER2 status by immunohistochemistry on prostate cancer biopsy samples III Study associations between HER2 protein expression on tumor cells and post-therapy changes in PSA in this patient population
OUTLINE Patients receive trastuzumab IV over 30 or 90 minutes once a week Treatment continues for a maximum of 24 weeks in the absence of unacceptable toxicity or disease progression Patients are followed for time to progression
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study within 6-9 months
OUTLINE Patients receive trastuzumab IV over 30 or 90 minutes once a week Treatment continues for a maximum of 24 weeks in the absence of unacceptable toxicity or disease progression Patients are followed for time to progression
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study within 6-9 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 |
|---|---|---|---|
| CDR0000066857 | REGISTRY | None | None |
| NCI-G99-1493 | Registry Identifier | PDQ Physician Data Query | None |