Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066352
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2003-08-06
Brief Title:
Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder Renal Pelvis or Ureter
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study of PS-341 in Advanced or Metastatic Urothelial Cancer Transitional Cell Cancer of the Bladder Ureter and Renal Pelvis
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase II trial is studying how well bortezomib works in treating patients with advanced or metastatic transitional cell cancer of the bladder renal pelvis or ureter
PURPOSE This phase II trial is studying how well bortezomib works in treating patients with advanced or metastatic transitional cell cancer of the bladder renal pelvis or ureter
Detailed Description:
OBJECTIVES
Determine the response rate and duration of response in patients with advanced or metastatic transitional cell cancer of the bladder renal pelvis or ureter when treated with bortezomib
Determine the 1-year median and overall survival rate of patients treated with this drug
Determine the stable disease rate and duration and time to progression in patients treated with this drug
Determine the toxicity of this drug in these patients
Correlate baseline and post-treatment levels of NF-kappaB and HIF-1 alpha in tumor biopsies with clinical outcome in patients treated with this drug
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients in complete remission CR may receive up to 2 courses after confirmation of CR
Patients are followed within 3 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within approximately 66-175 months
Determine the response rate and duration of response in patients with advanced or metastatic transitional cell cancer of the bladder renal pelvis or ureter when treated with bortezomib
Determine the 1-year median and overall survival rate of patients treated with this drug
Determine the stable disease rate and duration and time to progression in patients treated with this drug
Determine the toxicity of this drug in these patients
Correlate baseline and post-treatment levels of NF-kappaB and HIF-1 alpha in tumor biopsies with clinical outcome in patients treated with this drug
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients in complete remission CR may receive up to 2 courses after confirmation of CR
Patients are followed within 3 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within approximately 66-175 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-6150 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000315537 | REGISTRY | None | None |