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A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
This study has been completed.
First Received: April 30, 2002   Last Updated: July 18, 2006   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00034593
  Purpose

Definition: 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
 Drug: ALIMTA
Drug: gemcitabine
 Phase II

Study Type: Interventional
Study Design: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium
U.S. FDA Resources
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034593

Locations
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
"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."
Helsinki, 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."
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."
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."
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."
Paris Cedex 14, 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
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
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

Study ID Numbers: 4699, H3E-MC-JMEV
Study First Received: April 30, 2002
Last Updated: July 18, 2006
ClinicalTrials.gov Identifier: NCT00034593     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Bladder cancer
metastatic
transitional cell carcinoma of the urothelium

Study placed in the following topic categories:
Antimetabolites
Urinary Tract Neoplasm
Immunologic Factors
Urinary Bladder Neoplasms
Folate
Urogenital Neoplasms
Folinic Acid
Folic Acid Antagonists
Carcinoma, Transitional Cell
Urologic Neoplasms
Immunosuppressive Agents
 Antiviral Agents
Vitamin B9
Carcinoma
Folic Acid
Pemetrexed
Radiation-Sensitizing Agents
Bladder Neoplasm
Gemcitabine
Neoplasms, Glandular and Epithelial
Transitional Cell Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Urogenital Neoplasms
Folic Acid Antagonists
Carcinoma, Transitional Cell
 Urologic Neoplasms
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Pemetrexed
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009



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