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

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.

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Key information

Conditions

Superficial Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician

Sesto Fiorentino, Florence, 50019, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

Primary outcomes

To evaluate pathological complete response rate achieved by 6 week neoadjuvant intravesical administration of Gemcitabine followed by transurethral resection (TUR) or cold biopsies, in patients affected by low risk superficial bladder cancer .

Secondary outcomes

To assess toxicity profile in the same group of patients.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase II Study of 6 Weeks Intravesical Gemcitabine Instillation Followed By Transurethral Resection in Patients Affected By Superficial Bladder Cancer at Low Risk

Important dates

Study start: 2004
Study completion: 2005
First posted: Sep 19, 2005
Registry last updated: Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed