Bladder Cancer Clinical Trial

First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

Summary

The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic

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:

Patients in whom radiation or surgery is indicated
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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00389155

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 109 Locations for this study

See Locations Near You

University Of Alabama At Birmingham
Birmingham Alabama, 35294, United States
Acrc/Arizona Clinical Research Center, Inc.
Tucson Arizona, 85715, United States
Tower Hematology Oncology Medical Group
Beverly Hills California, 90211, United States
Local Institution
Concord California, 94520, United States
Glendale Memorial Hospital And Health Center
Glendale California, 91204, United States
Moores Ucsd Cancer Center
La Jolla California, 92093, United States
North Valley Hematology/Oncology Medical Group
Mission Hills California, 91345, United States
Local Institution
Orange California, 92868, United States
Stanford University
Stanford California, 94305, United States
Local Institution
Newark Delaware, 19718, United States
University Of Florida College Of Medicine At Jacksonville
Jacksonville Florida, 32209, United States
Local Institution
Jacksonville Florida, 32224, United States
Lakeland Regional Cancer Center
Lakeland Florida, 33805, United States
University Of Miami
Miami Florida, 33136, United States
Advanced Medical Specialties
Miami Florida, 33176, United States
Medical College Of Georgia
Augusta Georgia, 30912, United States
Central Georgia Cancer Care, Pc
Macon Georgia, 31201, United States
University Of Chicago
Chicago Illinois, 60637, United States
Springfield Clinic, Llp
Springfield Illinois, 62703, United States
Michiana Hematology Oncology, P.C.
South Bend Indiana, 46601, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore Maryland, 21231, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Mitchell Folbe, Md, Pc
Troy Michigan, 48085, United States
Local Institution
Minneapolis Minnesota, 55455, United States
Local Institution
Rochester Minnesota, 55905, United States
Missouri Cancer Associates
Columbia Missouri, 65201, United States
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
Columbia Missouri, 65203, United States
Capital Comprehensive Cancer Care Center
Jefferson City Missouri, 65109, United States
Kansas City Veterans Affairs Medical Center
Kansas City Missouri, 64128, United States
Washington University School Of Medicine
St. Louis Missouri, 63110, United States
Billings Clinic
Billings Montana, 59101, United States
Hematology Oncology Centers Of The Northern Rockies, Pc
Billings Montana, 59101, United States
Nevada Cancer Institute
Las Vegas Nevada, 89135, United States
Nevada Cancer Centers
Las Vegas Nevada, 89169, United States
The Cancer Center At Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Albert Einstein Cancer Center
Bronx New York, 10461, United States
The Mary Imogene Bassett Hospital
Cooperstown New York, 13326, United States
Columbia University Medical Center
New York New York, 10032, United States
New York Presbyterian Hospital
New York New York, 10065, United States
University Of Rochester
Rochester New York, 14642, United States
Carolinas Hematology Oncology Associates
Charlotte North Carolina, 28203, United States
Mid Dakota Clinic, Pc
Bismarck North Dakota, 58501, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Mid-Ohio Oncology/Hematology, Inc. Dba
Columbus Ohio, 43219, United States
Abramson Cancer Center Of The
Philadelphia Pennsylvania, 19104, United States
Guthrie Foundation For Education And Research
Sayre Pennsylvania, 18840, United States
Charleston Cancer Center
Charleston South Carolina, 29406, United States
Medical University Of South Carolina
Charleston South Carolina, 29425, United States
The Jones Clinic, Pc
Germantown Tennessee, 38138, United States
The West Clinic
Memphis Tennessee, 38120, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Lone Star Oncology Consulants, Pa
Austin Texas, 78759, United States
Cancer Specialists Of South Texas, Pa
Corpus Christi Texas, 78412, United States
The Center For Cancer And Blood Disorders
Fort Worth Texas, 76104, United States
University Of Texas Medical Branch Of Galveston
Galveston Texas, 77555, United States
South Texas Oncology And Hematology, P.A.
San Antonio Texas, 78207, United States
Northern Utah Associates
Ogden Utah, 84403, United States
Cancer Outreach Associates, Pc
Abingdon Virginia, 24211, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
Seattle Washington, 98195, United States
West Virginia University
Morgantown West Virginia, 26506, United States
Local Institution
Milwaukee Wisconsin, 53226, United States
Local Institution
Tweed Heads New South Wales, 2485, Australia
Local Institution
Adelaide South Australia, 5000, Australia
Local Institution
Antwerp , 2020, Belgium
Local Institution
Edegem , 2650, Belgium
Local Institution
Moncton New Brunswick, E1C 6, Canada
Local Institution
Sydney Nova Scotia, B1P 1, Canada
Local Institution
London Ontario, N6A 4, Canada
Local Institution
Montreal Quebec, H2L4M, Canada
Local Institution
Arhus , 8000, Denmark
Local Institution
Herlev , 2730, Denmark
Local Institution
Kobenhavn O , 2100, Denmark
Local Institution
Odense C , 5000, Denmark
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Caen Cedex 05 , 14076, France
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Paris Cedex 14 , 75679, France
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Vandoeuvre Les Nancy , 54511, France
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Athens , 11528, Greece
Local Institution
Jakarta , 11420, Indonesia
Local Institution
Milan , 20141, Italy
Local Institution
Trento , 38100, Italy
Local Institution
Viterbo , 01100, Italy
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Seongnam Gyeonggi-Do, 463-7, Korea, Republic of
Local Institution
Seoul , 110-7, Korea, Republic of
Local Institution
Seoul , 136-7, Korea, Republic of
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Cebu , 6000, Philippines
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Davao City , 8000, Philippines
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Manila , 1000, Philippines
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Quezon City , 1102, Philippines
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Bialystok , 15-27, Poland
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Cracow , 31-11, Poland
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Gdansk , 80-40, Poland
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Olsztyn , 10-22, Poland
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Poznan , 61-87, Poland
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Warsaw , 02-78, Poland
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Obninsk Kaluga Region, 24903, Russian Federation
Local Institution
Moscow , 12528, Russian Federation
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Saint Petersburg , 19506, Russian Federation
Local Institution
St Petersburg , 19825, Russian Federation
Local Institution
Barcelona , 08025, Spain
Local Institution
Barcelona , 08035, Spain
Local Institution
Murcia , 30008, Spain
Local Institution
Palma De Mallorca , 07198, Spain
Local Institution
Sabadell (Barcelona) , 08208, Spain
Local Institution
Santander , 39008, Spain
Local Institution
Bangkok , 10330, Thailand
Local Institution
Cardiff Glamorgan, CF14 , United Kingdom
Local Institution
Grimsby Lincolnshire, DN332, United Kingdom
Local Institution
Nottingham Nottinghamshire, NG51P, United Kingdom
Local Institution
Birmingham West Midlands, B15 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT00389155

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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