Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

Lilly

Status and phase

Terminated

Phase 3

Conditions

Bladder Neoplasms

Treatments

Drug: Placebo

Drug: Gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191477

6138

B9E-MC-S274

Details and patient eligibility

About

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.

Enrollment

355 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)