2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen

Phase 2

Completed

• Conditions: Urologic Neoplasms; Carcinoma, Transitional Cell

• Registration Number: NCT00191971
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for patients with transitional cell carcinoma of urothelium

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-05
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically and/or cytologically confirmed TCC
• Received 1st line chemotherapy for locally advanced or metastatic TCC with CDDP regimen
• To have at least one measurable region
• PS: 0-2
• To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria

• To have Interstitial pneumonia or pulmonary fibrosis
• Within 4 weeks after the latest chemotherapy or radiotherapy
• To have brain metastasis with symptom
• To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Progression-free survival
Overall survival

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; 🇯🇵 Tokyo, Japan