Intravesical Chemotherapy Treatment of Superficial Bladder Cancer

Phase 2

Completed

• Conditions: Bladder Neoplasms

• Registration Number: NCT00491114
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study Completion: 2004-08
• Status Verified: 2007-06
• Study First Submitted: 2007-06-21
• Study First Submitted QC: 2007-06-21
• Last Update Submitted: 2007-06-21
• Study First Posted: 2007-06-25
• Last Update Posted: 2007-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the response rate

Secondary Outcome Measures

Name	Time	Method
To define the relapse free survival
To assess toxicity profile

Trial Locations

Locations (1)

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.; 🇮🇹 Varese, Italy