Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014287
Status:
WITHDRAWN
Last Update Posted:
2013-12-19
First Post:
2001-04-10
Brief Title:
Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Intravesical Gemcitabine Therapy for BCG-Refractory Superficial Bladder Cancer A Phase I and Pharmacokinetic Study
Status:
WITHDRAWN
Status Verified Date:
2013-12
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 Giving the drugs in different ways may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of gemcitabine given directly into the bladder in treating patients who have recurrent or refractory bladder cancer
PURPOSE Phase I trial to study the effectiveness of gemcitabine given directly into the bladder in treating patients who have recurrent or refractory bladder cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of intravesical gemcitabine in patients with recurrent or refractory superficial bladder cancer II Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients III Assess any responses in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study Patients receive intravesical gemcitabine that is left in the bladder for 2 hours and then removed on day 1 Treatment continues every 7 days for 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of intravesical gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study
OUTLINE This is a dose-escalation multicenter study Patients receive intravesical gemcitabine that is left in the bladder for 2 hours and then removed on day 1 Treatment continues every 7 days for 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of intravesical gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068527 | REGISTRY | None | None |
| LILLY-PCI-99039 | None | None | None |
| PCI-IRB-990814 | None | None | None |
| NCI-G01-1926 | Registry Identifier | PDQ Physician Data Query | None |