Status:
TERMINATED
Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral re...
Eligibility Criteria
Inclusion
- Clinical evidence of superficial transitional cell carcinoma of the bladder
- Males or females at least 18 years of age
- Karnofsky Performance Status greater than or equal to 70%
- Patient compliance and geographic proximity that allow adequate follow-up
- Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
- Signed informed consent.
Exclusion
- Clinical evidence of muscle-invasive or locally advanced bladder cancer
- Clinical evidence of upper urinary tract tumor
- Distant metastases
- Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
- Severe concomitant psychiatric disease
- Febrile, active infection
- Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00191477
Start Date
January 1 2004
End Date
June 1 2008
Last Update
October 28 2009
Active Locations (1)
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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 physici
Reinfeld, Germany, 23858