Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00389155
Registration number
NCT00389155
Ethics application status
Date submitted
17/10/2006
Date registered
18/10/2006
Date last updated
7/12/2015
Titles & IDs
Public title
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
CA183-002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer
0
0
Query!
Transitional Cell Carcinoma
0
0
Query!
Metastasis
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Cancer
0
0
0
0
Query!
Bladder - transitional cell cancer
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Vinflunine
Treatment: Drugs - Gemcitabine
Other interventions - Placebo
Experimental: vinflunine and gemcitabine - solution for injection, IV, vinflunine: 280/320 mg/m2 + 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
Treatment: Drugs: Vinflunine
solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Treatment: Drugs: Gemcitabine
solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
Other interventions: Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Query!
Secondary outcome [1]
0
0
Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Query!
Secondary outcome [2]
0
0
Overall Survival of Participants With TCC of the Urothelium
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Query!
Secondary outcome [3]
0
0
Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Query!
Secondary outcome [4]
0
0
Duration of Response in Participants With Best Response of CR or PR
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Query!
Secondary outcome [5]
0
0
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Query!
Secondary outcome [6]
0
0
Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Following Day 1 to no longer than 30 days after last dose of study medication
Query!
Secondary outcome [7]
0
0
Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Following Day 1 to no longer than 30 days after last dose of study medication
Query!
Secondary outcome [8]
0
0
Time to Response in Participants With Best Response of CR or PR
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2/Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
34
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA
Query!
Recruitment hospital [1]
0
0
Local Institution - Tweed Heads
Query!
Recruitment hospital [2]
0
0
Local Institution - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [2]
0
0
5000 - Adelaide
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Delaware
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Montana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nevada
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Dakota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Washington
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
West Virginia
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Wisconsin
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Antwerp
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Edegem
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
New Brunswick
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Nova Scotia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Ontario
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Quebec
Query!
Country [36]
0
0
Denmark
Query!
State/province [36]
0
0
Arhus
Query!
Country [37]
0
0
Denmark
Query!
State/province [37]
0
0
Herlev
Query!
Country [38]
0
0
Denmark
Query!
State/province [38]
0
0
Kobenhavn O
Query!
Country [39]
0
0
Denmark
Query!
State/province [39]
0
0
Odense C
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Caen Cedex 05
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Paris Cedex 14
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Vandoeuvre Les Nancy
Query!
Country [43]
0
0
Greece
Query!
State/province [43]
0
0
Athens
Query!
Country [44]
0
0
Indonesia
Query!
State/province [44]
0
0
Jakarta
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Milan
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Trento
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Viterbo
Query!
Country [48]
0
0
Korea, Republic of
Query!
State/province [48]
0
0
Gyeonggi-Do
Query!
Country [49]
0
0
Korea, Republic of
Query!
State/province [49]
0
0
Seoul
Query!
Country [50]
0
0
Philippines
Query!
State/province [50]
0
0
Cebu
Query!
Country [51]
0
0
Philippines
Query!
State/province [51]
0
0
Davao City
Query!
Country [52]
0
0
Philippines
Query!
State/province [52]
0
0
Manila
Query!
Country [53]
0
0
Philippines
Query!
State/province [53]
0
0
Quezon City
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Bialystok
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Cracow
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Gdansk
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Olsztyn
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Poznan
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Warsaw
Query!
Country [60]
0
0
Russian Federation
Query!
State/province [60]
0
0
Kaluga Region
Query!
Country [61]
0
0
Russian Federation
Query!
State/province [61]
0
0
Moscow
Query!
Country [62]
0
0
Russian Federation
Query!
State/province [62]
0
0
Saint Petersburg
Query!
Country [63]
0
0
Russian Federation
Query!
State/province [63]
0
0
St Petersburg
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Barcelona
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Murcia
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Palma De Mallorca
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
Sabadell (Barcelona)
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Santander
Query!
Country [69]
0
0
Thailand
Query!
State/province [69]
0
0
Bangkok
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Glamorgan
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Lincolnshire
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Nottinghamshire
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
West Midlands
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00389155
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00389155
Download to PDF