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

Eli Lilly and Company1 site in 1 country355 target enrollmentJanuary 2004

ConditionsBladder Neoplasms

InterventionsGemcitabine Placebo

DrugsGemcitabine Placebo

Overview

Phase: Phase 3
Intervention: Gemcitabine
Conditions: Bladder Neoplasms
Sponsor: Eli Lilly and Company
Enrollment: 355
Locations: 1
Primary Endpoint: Recurrence-Free Survival (RFS)
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 resection of the bladder tumor.

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

June 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility 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)

Arms & Interventions

A

Intervention: Gemcitabine

B

Intervention: Placebo

Outcomes

Primary Outcomes

Recurrence-Free Survival (RFS)

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)

Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.

Secondary Outcomes

Time to Recurrence(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))
Recurrence-Free Survival (RFS) in Subgroups(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))
Tumor Recurrence Type(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))