Clinical trial NCT00034593: A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urologic Neoplasms
Keywords: Bladder cancer
metastatic
transitional cell carcinoma of the urothelium
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: "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."
city: Pikonlinna
country: Finland
facility: "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."
city: Turku
country: Finland
facility: "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."
city: Bordeaux Cedex
country: France
facility: "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."
city: Lille Cedex
country: France
facility: 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.
city: Marseille Cedex 09
country: France
facility: "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."
city: Montpellier
country: France
facility: "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."
city: Paris Cedex 14
country: France
facility: "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."
city: Homburg/Saar
country: Germany
facility: 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.
Study officials:
References: