Back to resultsA Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
Primary Purpose
Urologic Neoplasms, Metastases, Neoplasm
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Neoplasms focused on measuring Bladder Cancer, Metastatic, Recurrent, Transitional cell carcinoma of the urothelium
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00035061
Brief Title
A Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Neoplasms, Metastases, Neoplasm
Keywords
Bladder Cancer, Metastatic, Recurrent, Transitional cell carcinoma of the urothelium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
pemetrexed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
Boca Raton
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Decatur
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lafayette
State/Province
Indiana
Country
United States
City
Muncie
State/Province
Indiana
Country
United States
City
South Bend
State/Province
Indiana
Country
United States
City
Lenexa
State/Province
Kansas
Country
United States
City
Saint Mathews
State/Province
Kentucky
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
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