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

November 6, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vinflunine and gemcitabine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
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
Placebo Comparator: placebo and gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Other: Placebo
Drug: Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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
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.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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
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.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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
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.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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
Following Day 1 to no longer than 30 days after last dose of study medication
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
Following Day 1 to no longer than 30 days after last dose of study medication
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
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.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 18, 2006

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA183-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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