First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
NCT ID: NCT00389155
Last Updated: 2015-12-07
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/PHASE3
34 participants
INTERVENTIONAL
2007-01-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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vinflunine and gemcitabine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Vinflunine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
placebo and gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Placebo
Interventions
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Vinflunine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Placebo
Eligibility Criteria
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Inclusion Criteria
* Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
* Calculated creatinine clearance ≤60 mL/min: OR
* New York Heart Association Classification Stage III-IV Congestive Heart Failure
* Measurable disease documented by imaging with at least one uni-dimensional lesion
* Adequate performance status (ECOG 0, 1, or 2)
* Men and women ≥18 years of age
Exclusion Criteria
* Current neuropathy ≥ CTCAE grade 3
* Prior radiation to ≥ 30% of bone marrow
* Inadequate renal function: serum creatinine clearance ≤ 20 mL/min
* Prior allergy to any vinca alkaloid
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States
Local Institution
Concord, California, United States
Glendale Memorial Hospital And Health Center
Glendale, California, United States
Moores Ucsd Cancer Center
La Jolla, California, United States
North Valley Hematology/Oncology Medical Group
Mission Hills, California, United States
Local Institution
Orange, California, United States
Stanford University
Stanford, California, United States
Local Institution
Newark, Delaware, United States
University Of Florida College Of Medicine At Jacksonville
Jacksonville, Florida, United States
Local Institution
Jacksonville, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
University Of Miami
Miami, Florida, United States
Advanced Medical Specialties
Miami, Florida, United States
Medical College Of Georgia
Augusta, Georgia, United States
Central Georgia Cancer Care, Pc
Macon, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Springfield Clinic, Llp
Springfield, Illinois, United States
Michiana Hematology Oncology, P.C.
South Bend, Indiana, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mitchell Folbe, Md, Pc
Troy, Michigan, United States
Local Institution
Minneapolis, Minnesota, United States
Local Institution
Rochester, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
Columbia, Missouri, United States
Capital Comprehensive Cancer Care Center
Jefferson City, Missouri, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
Hematology Oncology Centers Of The Northern Rockies, Pc
Billings, Montana, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Nevada Cancer Centers
Las Vegas, Nevada, United States
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States
The Mary Imogene Bassett Hospital
Cooperstown, New York, United States
Columbia University Medical Center
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
University Of Rochester
Rochester, New York, United States
Albert Einstein Cancer Center
The Bronx, New York, United States
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, United States
Mid Dakota Clinic, Pc
Bismarck, North Dakota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Mid-Ohio Oncology/Hematology, Inc. Dba
Columbus, Ohio, United States
Abramson Cancer Center Of The
Philadelphia, Pennsylvania, United States
Guthrie Foundation For Education And Research
Sayre, Pennsylvania, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
The Jones Clinic, Pc
Germantown, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Lone Star Oncology Consulants, Pa
Austin, Texas, United States
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States
The Center For Cancer And Blood Disorders
Fort Worth, Texas, United States
University Of Texas Medical Branch Of Galveston
Galveston, Texas, United States
South Texas Oncology And Hematology, P.A.
San Antonio, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Cancer Outreach Associates, Pc
Abingdon, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Local Institution
Milwaukee, Wisconsin, United States
Local Institution
Tweed Heads, New South Wales, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Antwerp, Antwerp, Belgium
Local Institution
Edegem, , Belgium
Local Institution
Moncton, New Brunswick, Canada
Local Institution
Sydney, Nova Scotia, Canada
Local Institution
London, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Aarhus, , Denmark
Local Institution
Herlev, , Denmark
Local Institution
København Ø, , Denmark
Local Institution
Odense C, , Denmark
Local Institution
Caen, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Athens, , Greece
Local Institution
Jakarta, , Indonesia
Local Institution
Milan, , Italy
Local Institution
Trento, , Italy
Local Institution
Viterbo, , Italy
Local Institution
Cebu, , Philippines
Local Institution
Davao City, , Philippines
Local Institution
Manila, , Philippines
Local Institution
Quezon City, , Philippines
Local Institution
Bialystok, , Poland
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Gdansk, , Poland
Local Institution
Krakow, , Poland
Local Institution
Olsztyn, , Poland
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Poznan, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Obninsk, Kaluga Oblast, Russia
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Seongnam-si, Gyeonggi-do, South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Murcia, , Spain
Local Institution
Palma de Mallorca, , Spain
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Sabadell (Barcelona), , Spain
Local Institution
Santander, , Spain
Local Institution
Bangkok, , Thailand
Local Institution
Cardiff, Glamorgan, United Kingdom
Local Institution
Grimsby, Lincolnshire, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Countries
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Other Identifiers
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CA183-002
Identifier Type: -
Identifier Source: org_study_id