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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Primary solitary bladder tumour not exceeding 2 cm of diameter at sonography and/or at cystoscopy, judged by the investigator not muscle infiltrating and at low risk

• Urinary cytology negative for severe dysplasia (G3).

• ECOG performance status 0-1

• Absence of anti-coagulant therapy or acetyl-salicylic acid chronic therapy

• Absence of other present or past neoplasias except for healed skin basalioma

Exclusion Criteria:

• Tumours with infiltrative patterns at cystoscopy

• Transitional carcinoma of the upper urinary tract and prostatic urethra.

• Any previous or concomitant malignancy other than superficial bladder cancer with the exception of cutaneous basalioma and/or cancer of the cervix, adequately treated.