Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025376
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2001-10-11
Brief Title:
PS-341 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
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 It is not yet known which regimen of PS-341 is more effective in treating metastatic kidney cancer
PURPOSE Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer
PURPOSE Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib
Determine the time to tumor progression and 1-year survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo core biopsy
Arm II Patients undergo core biopsy Patients then receive bortezomib IV as in arm I
Patients undergo radiologic re-evaluation of measurable lesions Patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity
Patients are followed for 2 years
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 9-14 months
Determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib
Determine the time to tumor progression and 1-year survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients then undergo core biopsy
Arm II Patients undergo core biopsy Patients then receive bortezomib IV as in arm I
Patients undergo radiologic re-evaluation of measurable lesions Patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity
Patients are followed for 2 years
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 9-14 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-3291 | None | None | None |
| UCCRC-11049A | None | None | None |