A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00034593 |
Recruitment Status :
Completed
First Posted : May 1, 2002
Last Update Posted : July 19, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urologic Neoplasms | Drug: ALIMTA Drug: gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00034593
Finland | |
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." | |
Helsinki, Finland | |
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." | |
Pikonlinna, Finland | |
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." | |
Turku, Finland | |
France | |
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." | |
Bordeaux Cedex, France | |
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician. | |
Lille Cedex, France | |
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." | |
Marseille Cedex 09, France | |
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." | |
Montpellier, France | |
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician." | |
Paris Cedex 14, France | |
Germany | |
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician. | |
Homburg/Saar, Germany |
ClinicalTrials.gov Identifier: | NCT00034593 |
Other Study ID Numbers: |
4699 H3E-MC-JMEV |
First Posted: | May 1, 2002 Key Record Dates |
Last Update Posted: | July 19, 2006 |
Last Verified: | July 2006 |
Bladder cancer metastatic transitional cell carcinoma of the urothelium |
Carcinoma, Transitional Cell Urologic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urogenital Neoplasms Neoplasms by Site Gemcitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |