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A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

NCT ID: NCT00034593

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Urologic Neoplasms

Keywords

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Bladder cancer metastatic transitional cell carcinoma of the urothelium

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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ALIMTA

Intervention Type DRUG

gemcitabine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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"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

Site Status

"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

Site Status

"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

Site Status

"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, , France

Site Status

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, , France

Site Status

"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, , France

Site Status

"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

Site Status

"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, , France

Site Status

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

Site Status

Countries

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Finland France Germany

Other Identifiers

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H3E-MC-JMEV

Identifier Type: -

Identifier Source: secondary_id

4699

Identifier Type: -

Identifier Source: org_study_id