A Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00035061
First Posted: May 3, 2002
Last Update Posted: July 19, 2006
Information provided by:
Eli Lilly and Company
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Eligibility
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035061
Locations
| United States, California | |
| Los Angeles, California, United States | |
| Palo Alto, 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 | |
| Indianapolis, Indiana, United States | |
| Lafayette, 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 | |
| Philadelphia, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Fort Worth, Texas, United States | |
| Houston, Texas, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
Sponsors and Collaborators
Eli Lilly and Company
More Information
| ClinicalTrials.gov Identifier: | NCT00035061 History of Changes |
| Obsolete Identifiers: | NCT00039260 |
| Other Study ID Numbers: |
4698 H3E-MC-JMEU |
| First Submitted: | May 2, 2002 |
| First Posted: | May 3, 2002 |
| Last Update Posted: | July 19, 2006 |
| Last Verified: | July 2006 |
Keywords provided by Eli Lilly and Company:
|
Bladder Cancer Metastatic Recurrent Transitional cell carcinoma of the urothelium |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Neoplasm Metastasis Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urogenital Neoplasms Neoplasms by Site |
Neoplastic Processes Pathologic Processes Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |