A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium
Phase 2
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Urologic Neoplasms, Carcinoma, Transitional Cell
Both
Urologic Neoplasms, Carcinoma, Transitional Cell
Trial Information
A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Principal Investigator
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
7994
NCT ID:
NCT00191971
Start Date:
January 2004
Completion Date:
September 2006
Related Keywords:
- Urologic Neoplasms
- Carcinoma, Transitional Cell
- Transitional cell carcinoma of urothelium
- Neoplasms
- Carcinoma
- Carcinoma, Transitional Cell
- Urologic Neoplasms
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