Status:
COMPLETED
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Superficial Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 car...
Eligibility Criteria
Inclusion
- Histologically verified superficial transitional cell carcinoma of the bladder.
- patients with primary or recurrent intermediate risk superficial bladder cancer after TUR. Patients with primary tumor with stage TaG1 with multiple lesions (\>3) or lesions bigger than 3 cm or patients with TaG2-3 or T1G1-2.
- Patients must not be pre-treated with any intravesical immunotherapy (BCG) or chemotherapy.
- Male or female, age greater than 18.
Exclusion
- Time between TUR and start of intravesical chemotherapy will be longer than 4 weeks.
- Patients who have received previous (BCG) or chemotherapy.
- Patients with evidence of invasive, locally advanced or metastatic bladder cancer (greater than or equal to T2 disease; stage greater than or equal to B1) or patients with upper urinary tract disease.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00192049
Start Date
December 1 2003
End Date
April 1 2007
Last Update
May 17 2007
Active Locations (5)
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1
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Beersheba, Israel
2
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Haifa, Israel
3
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Jerusalem, Israel
4
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Kfar Saba, Israel