Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

• Time to Recurrence [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
• Recurrence-Free Survival (RFS) in Subgroups [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
• Tumor Recurrence Type [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]

• The secondary objectives:
• -To compare time to recurrence in both treatment arms
• -To compare the type of recurrence
• -To compare the recurrence-free survival in subgroups with and without subsequent BCG treatment
• -To compare the recurrence-free survival in subgroups with and without prior history of superficial bladder tumor(s)
• -To characterize the tolerability of a postoperative instillation of gemcitabine

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.

• Drug: Gemcitabine
  2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
  Other Names:

  • LY 188011
  • Gemzar
• Drug: Placebo
  intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

• Experimental: A
  Intervention: Drug: Gemcitabine
• Placebo Comparator: B
  Intervention: Drug: Placebo

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)