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

July 18, 2006 updated by: Eli Lilly and Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: pemetrexed

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States
  - Palo Alto, California, United States
- Florida
  - Boca Raton, Florida, United States
  - Tampa, Florida, United States
- Illinois
  - Decatur, Illinois, United States
- Indiana
  - Indianapolis, Indiana, United States
  - Lafayette, Indiana, United States
  - Muncie, Indiana, United States
  - South Bend, Indiana, United States
- Kansas
  - Lenexa, Kansas, United States
- Kentucky
  - Saint Mathews, Kentucky, United States
- Massachusetts
  - Boston, Massachusetts, United States
- Nebraska
  - Omaha, Nebraska, United States
- Ohio
  - Cleveland, Ohio, United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States
  - Pittsburgh, Pennsylvania, United States
- Tennessee
  - Nashville, Tennessee, United States
- Texas
  - Fort Worth, Texas, United States
  - Houston, Texas, United States
- Washington
  - Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

4698
H3E-MC-JMEU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.