Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
NCT ID: NCT00101608
Last Updated: 2010-03-02
Study Results
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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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2005-01-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
Interventions
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vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration
Eligibility Criteria
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Inclusion Criteria
* Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
* Adequate performance status (Karnofsky greater or equal to 80).
Exclusion Criteria
* Prior discontinuation of platinum due solely to toxicity.
* Current neuropathy greater or equal to CTC grade 2.
* Prior radiation to greater or equal to 30% of bone marrow.
* Inadequate hematologic function: ANC \<1,500 cells/mm3, Platelet\<100,000 cells/mm3.
* Inadequate hepatic function: total bilirubin \> 1.5 times ULN, ALT/AST \> 2.5 times ULN or \> 5 times ULN in case of liver metastasis.
* Inadequate renal function: creatinine clearance \<20 ml/min.
* Prior allergy to any vinca-alkaloid.
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Beverly Hills, California, United States
Local Institution
La Jolla, California, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Vallejo, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Joliet, Illinois, United States
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Urbana, Illinois, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Burlington, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Buffalo, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Liverpool, New South Wales, Australia
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Sydney, New South Wales, Australia
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Taree, New South Wales, Australia
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Waratah, New South Wales, Australia
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Westmead, New South Wales, Australia
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Adelaide, South Australia, Australia
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Linz, , Austria
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Salzburg, , Austria
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Edmonton, Alberta, Canada
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London, Ontario, Canada
Local Insitution
Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Caen, , France
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Le Mans, , France
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Nice, , France
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Paris, , France
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Toulouse, , France
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Nea Liosia, , Greece
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Jakarta, , Indonesia
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Genova, , Italy
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Milan, , Italy
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Roma, , Italy
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Rome, , Italy
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Viterbo, , Italy
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Cebu City, , Philippines
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Quezon, , Philippines
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Quezon City, , Philippines
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Singapore, , Singapore
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Seoul, , South Korea
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Murcia, , Spain
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Palma de Mallorca, , Spain
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Santander, , Spain
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Seville, , Spain
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Linköping, , Sweden
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Uppsala, , Sweden
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Aarau, , Switzerland
Local Institution
Bangkok, , Thailand
Countries
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Other Identifiers
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CA183-001
Identifier Type: -
Identifier Source: org_study_id
NCT00268424
Identifier Type: -
Identifier Source: nct_alias
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