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.
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
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There are 109 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85715, United States
Beverly Hills California, 90211, United States
Concord California, 94520, United States
Glendale California, 91204, United States
La Jolla California, 92093, United States
Mission Hills California, 91345, United States
Orange California, 92868, United States
Stanford California, 94305, United States
Newark Delaware, 19718, United States
Jacksonville Florida, 32209, United States
Jacksonville Florida, 32224, United States
Lakeland Florida, 33805, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Augusta Georgia, 30912, United States
Macon Georgia, 31201, United States
Chicago Illinois, 60637, United States
Springfield Illinois, 62703, United States
South Bend Indiana, 46601, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21231, United States
Detroit Michigan, 48202, United States
Troy Michigan, 48085, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65203, United States
Jefferson City Missouri, 65109, United States
Kansas City Missouri, 64128, United States
St. Louis Missouri, 63110, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Las Vegas Nevada, 89135, United States
Las Vegas Nevada, 89169, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10461, United States
Cooperstown New York, 13326, United States
New York New York, 10032, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28203, United States
Bismarck North Dakota, 58501, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43219, United States
Philadelphia Pennsylvania, 19104, United States
Sayre Pennsylvania, 18840, United States
Charleston South Carolina, 29406, United States
Charleston South Carolina, 29425, United States
Germantown Tennessee, 38138, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78759, United States
Corpus Christi Texas, 78412, United States
Fort Worth Texas, 76104, United States
Galveston Texas, 77555, United States
San Antonio Texas, 78207, United States
Ogden Utah, 84403, United States
Abingdon Virginia, 24211, United States
Norfolk Virginia, 23502, United States
Seattle Washington, 98101, United States
Seattle Washington, 98195, United States
Morgantown West Virginia, 26506, United States
Milwaukee Wisconsin, 53226, United States
Tweed Heads New South Wales, 2485, Australia
Adelaide South Australia, 5000, Australia
Antwerp , 2020, Belgium
Edegem , 2650, Belgium
Moncton New Brunswick, E1C 6, Canada
Sydney Nova Scotia, B1P 1, Canada
London Ontario, N6A 4, Canada
Montreal Quebec, H2L4M, Canada
Arhus , 8000, Denmark
Herlev , 2730, Denmark
Kobenhavn O , 2100, Denmark
Odense C , 5000, Denmark
Caen Cedex 05 , 14076, France
Paris Cedex 14 , 75679, France
Vandoeuvre Les Nancy , 54511, France
Athens , 11528, Greece
Jakarta , 11420, Indonesia
Milan , 20141, Italy
Trento , 38100, Italy
Viterbo , 01100, Italy
Seongnam Gyeonggi-Do, 463-7, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 136-7, Korea, Republic of
Cebu , 6000, Philippines
Davao City , 8000, Philippines
Manila , 1000, Philippines
Quezon City , 1102, Philippines
Bialystok , 15-27, Poland
Cracow , 31-11, Poland
Gdansk , 80-40, Poland
Olsztyn , 10-22, Poland
Poznan , 61-87, Poland
Warsaw , 02-78, Poland
Obninsk Kaluga Region, 24903, Russian Federation
Moscow , 12528, Russian Federation
Saint Petersburg , 19506, Russian Federation
St Petersburg , 19825, Russian Federation
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Murcia , 30008, Spain
Palma De Mallorca , 07198, Spain
Sabadell (Barcelona) , 08208, Spain
Santander , 39008, Spain
Bangkok , 10330, Thailand
Cardiff Glamorgan, CF14 , United Kingdom
Grimsby Lincolnshire, DN332, United Kingdom
Nottingham Nottinghamshire, NG51P, United Kingdom
Birmingham West Midlands, B15 2, United Kingdom
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