Skip to main content
OpenTrials
Completed

NCT Number: NCT00491114

Intravesical Chemotherapy Treatment of Superficial Bladder Cancer

This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site 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, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Superficial bladder cancer
  • No prior chemotherapy

Exclusion criteria

  • Grade 3 tumors
  • Papillary tumors invading connective tissue
  • Significant urologic disease, possible interfering with intravesical therapy

Treatment and study plan

Gemcitabine

Drug

Primary outcomes

  1. To evaluate the response rate

Secondary outcomes

  1. To define the relapse free survival

  2. To assess toxicity profile

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Intravesical Gemcitabine Therapy in Intermediate Risk Superficial Bladder Cancer: A Phase II Study With the Marker Lesion

Important dates

Study start
2003
Study completion
2004
First posted
Jun 25, 2007
Registry last updated
Jun 25, 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.

Related clinical trials

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