Status:
COMPLETED
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
Lead Sponsor:
Eli Lilly and Company
Conditions:
Superficial Bladder Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystosc...
Eligibility Criteria
Inclusion
- Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk
- Urinary cytology negative for severe dysplasia (G3).
- ECOG performance status 0-1
- Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy
- Absence of other present or past neoplasias except for healed skin basalioma
Exclusion
- Tumours with infiltrative patterns at cystoscopy
- Transitional carcinoma of the upper urinary tract and prostatic urethra.
- Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00191711
Start Date
February 1 2004
End Date
October 1 2005
Last Update
January 26 2007
Active Locations (1)
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1
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