Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017199
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2001-06-06
Brief Title:
PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2007-05
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic neuroendocrine tumors
PURPOSE Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic neuroendocrine tumors
Detailed Description:
OBJECTIVES
Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with bortezomib
Determine the toxicity of this drug in this patient population
Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond CR
PROJECTED ACCRUAL A total of 16-25 patients will be accrued for this study within 6 months
Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with bortezomib
Determine the toxicity of this drug in this patient population
Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond CR
PROJECTED ACCRUAL A total of 16-25 patients will be accrued for this study within 6 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-1856 | None | None | None |
| OSU-00H0328 | None | None | None |