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

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
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 November 20, 2008