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

Phase 2

Completed

• Conditions: Urologic Neoplasms; Metastases, Neoplasm

• Registration Number: NCT00035061
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified