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

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.
 
ClinicalTrials.gov Identifier: NCT00035061
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urologic Neoplasms Metastases, Neoplasm Drug: pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035061


Locations
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United States, California
Los Angeles, California, United States
Palo Alto, California, United States
United States, Florida
Boca Raton, Florida, United States
Tampa, Florida, United States
United States, Illinois
Decatur, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
Lafayette, Indiana, United States
Muncie, Indiana, United States
South Bend, Indiana, United States
United States, Kansas
Lenexa, Kansas, United States
United States, Kentucky
Saint Mathews, Kentucky, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Fort Worth, Texas, United States
Houston, Texas, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Eli Lilly and Company
More Information
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ClinicalTrials.gov Identifier: NCT00035061    
Obsolete Identifiers: NCT00039260
Other Study ID Numbers: 4698
H3E-MC-JMEU
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006
Keywords provided by Eli Lilly and Company:
Bladder Cancer
Metastatic
Recurrent
Transitional cell carcinoma of the urothelium
Additional relevant MeSH terms:
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Neoplasm Metastasis
Carcinoma, Transitional Cell
Urologic Neoplasms
Neoplasms
Neoplastic Processes
Pathologic Processes
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Urogenital Neoplasms
Neoplasms by Site
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors