Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
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|ClinicalTrials.gov Identifier: NCT00191711|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Superficial Bladder Cancer||Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk|
|Study Start Date :||February 2004|
|Study Completion Date :||October 2005|
- To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer .
- To assess toxicity profile in the same group of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191711
|For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician|
|Sesto Fiorentino, Florence, Italy, 50019|
|Study Chair:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|