Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: November 5, 2007
Last verified: November 2007

September 12, 2005
November 5, 2007
January 2004
Not Provided
Response rate
Not Provided
Complete list of historical versions of study NCT00191971 on Archive Site
  • Progression-free survival
  • Overall survival
Not Provided
Not Provided
Not Provided
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

Not Provided
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Urologic Neoplasms
  • Carcinoma, Transitional Cell
Drug: Gemcitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2006
Not Provided

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)
20 Years to 74 Years
Contact information is only displayed when the study is recruiting subjects
7994, B9E-JE-BL21
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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