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

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00035061

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 II

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Palo Alto, California, United States

Los Angeles, 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

Lafayette, Indiana, United States

Indianapolis, 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

Pittsburgh, Pennsylvania, United States

Philadelphia, Pennsylvania, United States
United States, Tennessee

Nashville, Tennessee, United States
United States, Texas

Houston, Texas, United States

Fort Worth, Texas, United States
United States, Washington

Seattle, Washington, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information

Study ID Numbers:	4698, H3E-MC-JMEU
Study First Received:	May 2, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00035061
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

Study placed in the following topic categories:

Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Recurrence
Carcinoma

Pemetrexed
Folic Acid
Neoplasm Metastasis
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial
Bladder neoplasm

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists

Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009