Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072150
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2003-11-04
Brief Title:
Phase II Trial Of PS-341 Bortezomib In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of PS-341 Bortezomib in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
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:
Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth This phase II trial is studying how well bortezomib works in treating patients with advanced transitional cell carcinoma of the urothelium
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of PS-341 in patients with measurable advanced urothelial transitional cell carcinoma who have not responded to or have relapsed after one prior conventional chemotherapy
II To determine the safety and toxicity of PS-341 administered in this group of patients
III To estimate duration of objective response progression-free survival and overall survival in this group of patients
OUTLINE This is a 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 with a solitary site of disease ie lung or nodal metastases and who have a partial response PR may be considered for surgical resection Patients with a PR with residual disease after salvage surgery are eligible to continue study therapy Patients who achieve a complete response either through resection or bortezomib therapy receive 2 additional courses of study therapy
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 15-40 patients will be accrued for this study within 13-17 months
I To determine the efficacy of PS-341 in patients with measurable advanced urothelial transitional cell carcinoma who have not responded to or have relapsed after one prior conventional chemotherapy
II To determine the safety and toxicity of PS-341 administered in this group of patients
III To estimate duration of objective response progression-free survival and overall survival in this group of patients
OUTLINE This is a 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 with a solitary site of disease ie lung or nodal metastases and who have a partial response PR may be considered for surgical resection Patients with a PR with residual disease after salvage surgery are eligible to continue study therapy Patients who achieve a complete response either through resection or bortezomib therapy receive 2 additional courses of study therapy
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 15-40 patients will be accrued for this study within 13-17 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 |
|---|---|---|---|
| CALGB-90207 | None | None | None |
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |