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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.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00035061
First received: May 2, 2002
Last updated: July 18, 2006
Last verified: July 2006
History of Changes
  Purpose

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 Intervention Phase
Urologic Neoplasms
Metastases, Neoplasm
 Drug: pemetrexed
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035061

Locations
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

No publications provided

ClinicalTrials.gov Identifier: NCT00035061     History of Changes
Obsolete Identifiers: NCT00039260
Other Study ID Numbers: 4698, H3E-MC-JMEU
Study First Received: May 2, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Bladder Cancer
Metastatic
Recurrent
Transitional cell carcinoma of the urothelium

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Transitional Cell
Neoplasm Metastasis
Urologic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Urogenital Neoplasms
 Neoplasms by Site
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 21, 2013