Overview

Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

Status:
Terminated
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
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 resection of the bladder tumor.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Gemcitabine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)