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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Bladder CancerTransitional Cell CarcinomaMetastasis
Interventions
DRUG

Vinflunine

solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration

DRUG

Gemcitabine

solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

OTHER

Placebo

Trial Locations (112)

1000

Local Institution, Manila

1102

Local Institution, Quezon City

2020

Local Institution, Antwerp

2100

Local Institution, København Ø

2485

Local Institution, Tweed Heads

2650

Local Institution, Edegem

2730

Local Institution, Herlev

5000

Local Institution, Adelaide

Local Institution, Odense C

6000

Local Institution, Cebu

8000

Local Institution, Aarhus

Local Institution, Davao City

10032

Columbia University Medical Center, New York

10065

New York Presbyterian Hospital, New York

10330

Local Institution, Bangkok

10461

Albert Einstein Cancer Center, The Bronx

11420

Local Institution, Jakarta

11528

Local Institution, Athens

13326

The Mary Imogene Bassett Hospital, Cooperstown

14076

Local Institution, Caen

14642

University Of Rochester, Rochester

18840

Guthrie Foundation For Education And Research, Sayre

19104

Abramson Cancer Center Of The, Philadelphia

19718

Local Institution, Newark

20141

Local Institution, Milan

21231

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore

23502

Virginia Oncology Associates, Norfolk

24211

Cancer Outreach Associates, Pc, Abingdon

26506

West Virginia University, Morgantown

28203

Carolinas Hematology Oncology Associates, Charlotte

29406

Charleston Cancer Center, Charleston

29425

Medical University Of South Carolina, Charleston

30008

Local Institution, Murcia

30912

Medical College Of Georgia, Augusta

31201

Central Georgia Cancer Care, Pc, Macon

32209

University Of Florida College Of Medicine At Jacksonville, Jacksonville

32224

Local Institution, Jacksonville

33136

University Of Miami, Miami

33176

Advanced Medical Specialties, Miami

33805

Lakeland Regional Cancer Center, Lakeland

35294

University Of Alabama At Birmingham, Birmingham

37203

The Sarah Cannon Research Institute, Nashville

38100

Local Institution, Trento

38120

The West Clinic, Memphis

38138

The Jones Clinic, Pc, Germantown

39008

Local Institution, Santander

40202

James Graham Brown Cancer Center, Louisville

43219

Mid-Ohio Oncology/Hematology, Inc. Dba, Columbus

44195

Cleveland Clinic, Cleveland

46601

Michiana Hematology Oncology, P.C., South Bend

48085

Mitchell Folbe, Md, Pc, Troy

48202

Henry Ford Hospital, Detroit

53226

Local Institution, Milwaukee

54511

Local Institution, Vandœuvre-lès-Nancy

55455

Local Institution, Minneapolis

55905

Local Institution, Rochester

58501

Mid Dakota Clinic, Pc, Bismarck

59101

Billings Clinic, Billings

Hematology Oncology Centers Of The Northern Rockies, Pc, Billings

60637

University Of Chicago, Chicago

62703

Springfield Clinic, Llp, Springfield

63110

Washington University School Of Medicine, St Louis

64128

Kansas City Veterans Affairs Medical Center, Kansas City

65109

Capital Comprehensive Cancer Care Center, Jefferson City

65201

Missouri Cancer Associates, Columbia

65203

University Of Missouri Healthcare/Ellis Fischel Cancer Ctr, Columbia

75679

Local Institution, Paris

76104

The Center For Cancer And Blood Disorders, Fort Worth

77555

University Of Texas Medical Branch Of Galveston, Galveston

78207

South Texas Oncology And Hematology, P.A., San Antonio

78412

Cancer Specialists Of South Texas, Pa, Corpus Christi

78759

Lone Star Oncology Consulants, Pa, Austin

84403

Northern Utah Associates, Ogden

85715

Acrc/Arizona Clinical Research Center, Inc., Tucson

89135

Nevada Cancer Institute, Las Vegas

89169

Nevada Cancer Centers, Las Vegas

90211

Tower Hematology Oncology Medical Group, Beverly Hills

91204

Glendale Memorial Hospital And Health Center, Glendale

91345

North Valley Hematology/Oncology Medical Group, Mission Hills

92093

Moores Ucsd Cancer Center, La Jolla

92868

Local Institution, Orange

94305

Stanford University, Stanford

94520

Local Institution, Concord

98101

Virginia Mason Medical Center, Seattle

98195

Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr, Seattle

125284

Local Institution, Moscow

195067

Local Institution, Saint Petersburg

198255

Local Institution, Saint Petersburg

249036

Local Institution, Obninsk

07601

The Cancer Center At Hackensack University Medical Center, Hackensack

E1C 6Z8

Local Institution, Moncton

B1P 1P3

Local Institution, Sydney

N6A 4L6

Local Institution, London

H2L4MI

Local Institution, Montreal

01100

Local Institution, Viterbo

15-276

Local Institution, Bialystok

80-402

Local Institution, Gdansk

31-115

Local Institution, Krakow

10-228

Local Institution, Olsztyn

61-878-

Local Institution, Poznan

02-781

Local Institution, Warsaw

463-707

Local Institution, Seongnam-si

110-744

Local Institution, Seoul

136-705

Local Institution, Seoul

08025

Local Institution, Barcelona

08035

Local Institution, Barcelona

07198

Local Institution, Palma de Mallorca

08208

Local Institution, Sabadell (Barcelona)

CF14 2TL

Local Institution, Cardiff

DN332BA

Local Institution, Grimsby

NG51PB

Local Institution, Nottingham

B15 2TT

Local Institution, Birmingham

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY