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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00191971
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 6, 2007
Information provided by:
Eli Lilly and Company

September 12, 2005
September 19, 2005
November 6, 2007
January 2004
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Response rate
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Complete list of historical versions of study NCT00191971 on Archive Site
  • Progression-free survival
  • Overall survival
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2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen
A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium
To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for patients with transitional cell carcinoma of urothelium
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Urologic Neoplasms
  • Carcinoma, Transitional Cell
Drug: Gemcitabine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2006
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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)
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Eli Lilly and Company
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Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP