Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003175
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Continuous 5-Fluorouracil 5-FU in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract
Status:
COMPLETED
Status Verified Date:
2010-02
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
PURPOSE Phase II trial to study the effectiveness of fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer
PURPOSE Phase II trial to study the effectiveness of fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer
Detailed Description:
OBJECTIVES I Determine the response rate and toxic effects of continuous fluorouracil in patients with recurrent locally advanced or metastatic transitional cell urinary tract carcinoma II Determine the feasibility of this treatment in this patient population
OUTLINE Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24 weeks Patients are evaluated for complete and partial response at 8 16 and 24 weeks after the start of intravenous fluorouracil Patients experiencing disease progression or unacceptable toxic effects are removed from the study Patients are followed monthly for 6 months post treatment
PROJECTED ACCRUAL A maximum of 45 patients will be accrued
OUTLINE Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24 weeks Patients are evaluated for complete and partial response at 8 16 and 24 weeks after the start of intravenous fluorouracil Patients experiencing disease progression or unacceptable toxic effects are removed from the study Patients are followed monthly for 6 months post treatment
PROJECTED ACCRUAL A maximum of 45 patients will be accrued
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 |
|---|---|---|---|
| EU-97029 | None | None | None |
| MRC-BA10 | None | None | None |