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A Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium

This study has been completed.
Study NCT00035061.   Last updated on July 18, 2006.   Information provided by Eli Lilly and Company

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Descriptive Information Fields
Brief Title  A Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
Official Title 
Brief Summary

Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Urologic Neoplasms
Metastases, Neoplasm
Intervention  Drug: pemetrexed
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • You must have been diagnosed with bladder cancer that has recurred or moved to a new part of the body.
  • You must have at least one tumor that can be physically measured or scanned by x-ray.
  • You may not have had previous chemotherapy (drug) treatment OR you have had surgery followed by one chemotherapy treatment at least 4 months ago.

Exclusion Criteria:

  • You may not have used an experimental medicine or device within the past month.
  • Cancer that has spread to your brain.
  • If you are unwilling or unable to take folic acid or vitamin B12 supplements.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00035061
Organization ID 4698
Secondary IDs †† H3E-MC-JMEU
Study Sponsor  Eli Lilly and Company
Collaborators ††
Investigators 
Information Provided By Eli Lilly and Company
Verification Date July 2006
First Received Date  May 2, 2002
Last Updated Date July 18, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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