Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003814
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
Eflornithine in Treating Patients With Bladder Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Double-Blind Study of DFMO vs Placebo in Low Grade Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2007-05
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 It is not yet known if eflornithine is more effective than no further therapy in treating bladder cancer
PURPOSE Randomized phase III trial to determine the effectiveness of eflornithine in treating patients who have newly diagnosed or recurrent bladder cancer
PURPOSE Randomized phase III trial to determine the effectiveness of eflornithine in treating patients who have newly diagnosed or recurrent bladder cancer
Detailed Description:
OBJECTIVES I Determine whether treatment with eflornithine is effective in preventing recurrence of tumor after transurethral resection in patients with low grade superficial transitional cell carcinoma of the bladder II Determine the incidence and severity of toxicities associated with the long-term use of this drug in this patient population
OUTLINE This is a randomized double blind multicenter study Patients are stratified according to disease status newly diagnosed vs recurrent clinical stage Ta vs T1 grade G1 vs G2 and focus multifocal vs unifocal Patients receive either oral eflornithine or placebo once daily Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months during the first 2 years every 6 months for the third year and then annually for the fourth year
PROJECTED ACCRUAL A total of 450 patients 225 per arm will be accrued to this study within 15 years
OUTLINE This is a randomized double blind multicenter study Patients are stratified according to disease status newly diagnosed vs recurrent clinical stage Ta vs T1 grade G1 vs G2 and focus multifocal vs unifocal Patients receive either oral eflornithine or placebo once daily Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months during the first 2 years every 6 months for the third year and then annually for the fourth year
PROJECTED ACCRUAL A total of 450 patients 225 per arm will be accrued to this study within 15 years
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-G99-1509 | None | None | None |
| ILEX-DFMO341 | None | None | None |
| UCLA-9812049 | None | None | None |
| UF-453-1998 | None | None | None |
| WCCC-CO-98803 | None | None | None |