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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00389155
First received: October 17, 2006
Last updated: December 22, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Carcinoma
Metastasis
Drug: vinflunine and gemcitabine
Drug: placebo and gemcitabine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.


Secondary Outcome Measures:
  • Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Tumor response rate is defined as the number of participants in that arm whose best response is PR or CR, divided by the total number of randomized participants in the arm.

  • Overall Survival of Participants With TCC of the Urothelium [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Survival duration is defined as the time (in months) from randomization until death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.

  • Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD) [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Disease control rate is defined as the number of participants in that arm whose best response is PR, CR, or SD, divided by the total number of randomized participants in the treatment arm.

  • Duration of Response in Participants With Best Response of CR or PR [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Duration of response is computed for participants with best response of CR or PR; the duration is measured from the time measurement criteria are met for CR or PR, whichever is recorded first, until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.

  • Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation [ Designated as safety issue: Yes ]
    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.

  • Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade [ Time Frame: Following Day 1 to no longer than 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade [ Time Frame: Following Day 1 to no longer than 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
  • Time to Response in Participants With Best Response of CR or PR [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Time to response is defined as the number of months from the first dose of study therapy until measurement criteria are met for PR or CR, whichever is recorded first.


Enrollment: 34
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: vinflunine and gemcitabine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Placebo Comparator: 2 Drug: placebo and gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389155

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, California
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211
Local Institution
Concord, California, United States, 94520
Glendale Memorial Hospital And Health Center
Glendale, California, United States, 91204
Moores Ucsd Cancer Center
La Jolla, California, United States, 92093
North Valley Hematology/Oncology Medical Group
Mission Hills, California, United States, 91345
Local Institution
Orange, California, United States, 92868
Stanford University
Stanford, California, United States, 94305
United States, Delaware
Local Institution
Newark, Delaware, United States, 19718
United States, Florida
Local Institution
Jacksonville, Florida, United States, 32224
University Of Florida College Of Medicine At Jacksonville
Jacksonville, Florida, United States, 32209
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Advanced Medical Specialties
Miami, Florida, United States, 33176
University Of Miami
Miami, Florida, United States, 33136
United States, Georgia
Medical College Of Georgia
Augusta, Georgia, United States, 30912
Central Georgia Cancer Care, Pc
Macon, Georgia, United States, 31201
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Springfield Clinic, Llp
Springfield, Illinois, United States, 62703
United States, Indiana
Michiana Hematology Oncology, P.C.
South Bend, Indiana, United States, 46601
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Mitchell Folbe, Md, Pc
Troy, Michigan, United States, 48085
United States, Minnesota
Local Institution
Minneapolis, Minnesota, United States, 55455
Local Institution
Rochester, Minnesota, United States, 55905
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
Columbia, Missouri, United States, 65203
Capital Comprehensive Cancer Care Center
Jefferson City, Missouri, United States, 65109
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Washington University School Of Medicine
St. Louis, Missouri, United States, 63110
United States, Montana
Hematology Oncology Centers Of The Northern Rockies, Pc
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59101
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Nevada Cancer Centers
Las Vegas, Nevada, United States, 89169
United States, New Jersey
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Albert Einstein Cancer Center
Bronx, New York, United States, 10461
The Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Columbia University Medical Center
New York, New York, United States, 10032
New York Presbyterian Hospital
New York, New York, United States, 10065
University Of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, United States, 28203
United States, North Dakota
Mid Dakota Clinic, Pc
Bismarck, North Dakota, United States, 58501
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Mid-Ohio Oncology/Hematology, Inc. Dba
Columbus, Ohio, United States, 43219
United States, Pennsylvania
Abramson Cancer Center Of The
Philadelphia, Pennsylvania, United States, 19104
Guthrie Foundation For Education And Research
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Tennessee
The Jones Clinic, Pc
Germantown, Tennessee, United States, 38138
The West Clinic
Memphis, Tennessee, United States, 38120
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Lone Star Oncology Consulants, Pa
Austin, Texas, United States, 78759
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States, 78412
The Center For Cancer And Blood Disorders
Fort Worth, Texas, United States, 76104
University Of Texas Medical Branch Of Galveston
Galveston, Texas, United States, 77555
South Texas Oncology And Hematology, P.A.
San Antonio, Texas, United States, 78207
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84403
United States, Virginia
Cancer Outreach Associates, Pc
Abingdon, Virginia, United States, 24211
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
Seattle, Washington, United States, 98195
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Local Institution
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Local Institution
Tweed Heads, New South Wales, Australia, 2485
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Belgium
Local Institution
Antwerp, Belgium, 2020
Local Institution
Edegem, Belgium, 2650
Canada, New Brunswick
Local Institution
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Nova Scotia
Local Institution
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
Local Institution
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2L4MI
Denmark
Local Institution
Arhus, Denmark, 8000
Local Institution
Herlev, Denmark, 2730
Local Institution
Kobenhavn O, Denmark, 2100
Local Institution
Odense C, Denmark, 5000
France
Local Institution
Caen Cedex 05, France, 14076
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Vandoeuvre Les Nancy, France, 54511
Greece
Local Institution
Athens, Greece, 11528
Indonesia
Local Institution
Jakarta, Indonesia, 11420
Italy
Local Institution
Milan, Italy, 20141
Local Institution
Trento, Italy, 38100
Local Institution
Viterbo, Italy, 01100
Korea, Republic of
Local Institution
Seongnam, Gyeonggi-Do, Korea, Republic of, 463-707
Local Institution
Seoul, Korea, Republic of, 136-705
Local Institution
Seoul, Korea, Republic of, 110-744
Philippines
Local Institution
Cebu, Philippines, 6000
Local Institution
Davao City, Philippines, 8000
Local Institution
Manila, Philippines, 1000
Local Institution
Quezon City, Philippines, 1102
Poland
Local Institution
Bialystok, Poland, 15-276
Local Institution
Cracow, Poland, 31-115
Local Institution
Gdansk, Poland, 80-402
Local Institution
Olsztyn, Poland, 10-228
Local Institution
Poznan, Poland, 61-878-
Local Institution
Warsaw, Poland, 02-781
Russian Federation
Local Institution
Obninsk, Kaluga Region, Russian Federation, 249036
Local Institution
Moscow, Russian Federation, 125284
Local Institution
Saint Petersburg, Russian Federation, 195067
Local Institution
St Petersburg, Russian Federation, 198255
Spain
Local Institution
Barcelona, Spain, 08035
Local Institution
Barcelona, Spain, 08025
Local Institution
Murcia, Spain, 30008
Local Institution
Palma De Mallorca, Spain, 07198
Local Institution
Sabadell (Barcelona), Spain, 08208
Local Institution
Santander, Spain, 39008
Thailand
Local Institution
Bangkok, Thailand, 10330
United Kingdom
Local Institution
Cardiff, Glamorgan, United Kingdom, CF14 2TL
Local Institution
Grimsby, Lincolnshire, United Kingdom, DN332BA
Local Institution
Nottingham, Nottinghamshire, United Kingdom, NG51PB
Local Institution
Birmingham, West Midlands, United Kingdom, B15 2TT
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00389155     History of Changes
Other Study ID Numbers: CA183-002
Study First Received: October 17, 2006
Last Updated: December 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced or metastatic transitional cell carcinoma of the urothelium

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Neoplasm Metastasis
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 15, 2014