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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Gemcitabine

Criteria

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)