drugset / Trial / NCT00191711

Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.

NCT00191711 ↗

Phase 2 Completed 43 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the initial lesion.

Timeline

Start
2004-02
Primary completion
—
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule — Other