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

Lilly

Status and phase: Completed; Phase 2

Conditions: Superficial Bladder Cancer

Treatments: Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191711

8332

B9E-MC-S346

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)