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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
CA183-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Transitional Cell Carcinoma 0 0
Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

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 - 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.
Timepoint [1] 0 0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
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 - 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.
Timepoint [1] 0 0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Secondary outcome [2] 0 0
Overall Survival of Participants With TCC of the Urothelium - 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.
Timepoint [2] 0 0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Secondary outcome [3] 0 0
Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD) - 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.
Timepoint [3] 0 0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Secondary outcome [4] 0 0
Duration of Response in Participants With Best Response of CR or PR - 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.
Timepoint [4] 0 0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Secondary outcome [5] 0 0
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation - 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.
Timepoint [5] 0 0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
Secondary outcome [6] 0 0
Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade
Timepoint [6] 0 0
Following Day 1 to no longer than 30 days after last dose of study medication
Secondary outcome [7] 0 0
Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade
Timepoint [7] 0 0
Following Day 1 to no longer than 30 days after last dose of study medication
Secondary outcome [8] 0 0
Time to Response in Participants With Best Response of CR or PR - 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.
Timepoint [8] 0 0
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Local Institution - Tweed Heads
Recruitment hospital [2] 0 0
Local Institution - Adelaide
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Delaware
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Florida
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Illinois
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Indiana
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Kentucky
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Michigan
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Minnesota
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Missouri
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Nevada
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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West Virginia
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Wisconsin
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Belgium
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Antwerp
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Belgium
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Edegem
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Herlev
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Denmark
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Odense C
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France
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France
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France
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Athens
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Viterbo
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Seoul
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Davao City
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Poznan
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Warsaw
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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St Petersburg
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Barcelona
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Murcia
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Palma De Mallorca
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Sabadell (Barcelona)
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Spain
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Santander
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Thailand
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Bangkok
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United Kingdom
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Glamorgan
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United Kingdom
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Lincolnshire
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Nottinghamshire
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United Kingdom
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00389155
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications