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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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

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
Intervention code [1] 0 0
Treatment: Drugs
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
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
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
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)
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
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
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
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
Sex
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
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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
34
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
North Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
West Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerp
Country [31] 0 0
Belgium
State/province [31] 0 0
Edegem
Country [32] 0 0
Canada
State/province [32] 0 0
New Brunswick
Country [33] 0 0
Canada
State/province [33] 0 0
Nova Scotia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Denmark
State/province [36] 0 0
Arhus
Country [37] 0 0
Denmark
State/province [37] 0 0
Herlev
Country [38] 0 0
Denmark
State/province [38] 0 0
Kobenhavn O
Country [39] 0 0
Denmark
State/province [39] 0 0
Odense C
Country [40] 0 0
France
State/province [40] 0 0
Caen Cedex 05
Country [41] 0 0
France
State/province [41] 0 0
Paris Cedex 14
Country [42] 0 0
France
State/province [42] 0 0
Vandoeuvre Les Nancy
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Indonesia
State/province [44] 0 0
Jakarta
Country [45] 0 0
Italy
State/province [45] 0 0
Milan
Country [46] 0 0
Italy
State/province [46] 0 0
Trento
Country [47] 0 0
Italy
State/province [47] 0 0
Viterbo
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Gyeonggi-Do
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Philippines
State/province [50] 0 0
Cebu
Country [51] 0 0
Philippines
State/province [51] 0 0
Davao City
Country [52] 0 0
Philippines
State/province [52] 0 0
Manila
Country [53] 0 0
Philippines
State/province [53] 0 0
Quezon City
Country [54] 0 0
Poland
State/province [54] 0 0
Bialystok
Country [55] 0 0
Poland
State/province [55] 0 0
Cracow
Country [56] 0 0
Poland
State/province [56] 0 0
Gdansk
Country [57] 0 0
Poland
State/province [57] 0 0
Olsztyn
Country [58] 0 0
Poland
State/province [58] 0 0
Poznan
Country [59] 0 0
Poland
State/province [59] 0 0
Warsaw
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Kaluga Region
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Moscow
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saint Petersburg
Country [63] 0 0
Russian Federation
State/province [63] 0 0
St Petersburg
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
Country [65] 0 0
Spain
State/province [65] 0 0
Murcia
Country [66] 0 0
Spain
State/province [66] 0 0
Palma De Mallorca
Country [67] 0 0
Spain
State/province [67] 0 0
Sabadell (Barcelona)
Country [68] 0 0
Spain
State/province [68] 0 0
Santander
Country [69] 0 0
Thailand
State/province [69] 0 0
Bangkok
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Glamorgan
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Lincolnshire
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Nottinghamshire
Country [73] 0 0
United Kingdom
State/province [73] 0 0
West Midlands

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00389155