Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder

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.

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)