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

Urologic Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035061
• Other study ID #: 4698
• Secondary ID: H3E-MC-JMEU
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: July 18, 2006

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00039260

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Metastases, Neoplasm
• Neoplasm Metastasis
• Neoplasms
• Urologic Neoplasms

Intervention

Drug:
• pemetrexed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,