Trials / Completed
CompletedNCT00066352
Bortezomib in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 6.6-17.5 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bortezomib |
Timeline
- Start date
- 2003-09-01
- Primary completion
- 2003-09-01
- First posted
- 2003-08-07
- Last updated
- 2015-07-23
Locations
15 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00066352. Inclusion in this directory is not an endorsement.