Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192049
Status:
COMPLETED
Last Update Posted:
2007-05-17
First Post:
2005-09-12
Brief Title:
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk 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:
Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma On the basis of Gemcitabine clinical activity and good tolerability this drug has been recently tested in intravesical therapy we consider Gemcitabine as a good therapy candidate for patient with intermediate risk superficial bladder cancer Based on the phase III clinical trials w are going to explore the efficacy and tolerability of Gemcitabine in this setting and compare it to Mitomycin C which is widely used in this group of patients
Detailed Description:
None
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 |
|---|---|---|---|
| B9E-MC-S344 | None | None | None |