Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00101608




Registration number
NCT00101608
Ethics application status
Date submitted
12/01/2005
Date registered
13/01/2005
Date last updated
2/03/2010

Titles & IDs
Public title
Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
Scientific title
A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium
Secondary ID [1] 0 0
CA183-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transitional Cell Carcinoma 0 0
Bladder Neoplasms 0 0
Kidney Neoplasms 0 0
Ureter Neoplasms 0 0
Bladder Cancer 0 0
Neoplasm, Bladder 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
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vinflunine

Experimental: 1 -


Treatment: Drugs: vinflunine
solution for injection, IV, 280/320 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
To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.
Timepoint [1] 0 0
10-Apr-2007
Secondary outcome [1] 0 0
To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine
Timepoint [1] 0 0
10-April-2007

Eligibility
Key inclusion criteria
* Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
* Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
* Adequate performance status (Karnofsky greater or equal to 80).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Receipt of more than 1 prior chemotherapy regimen in any setting.
* Prior discontinuation of platinum due solely to toxicity.
* Current neuropathy greater or equal to CTC grade 2.
* Prior radiation to greater or equal to 30% of bone marrow.
* Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm3.
* Inadequate hepatic function: total bilirubin > 1.5 times ULN, ALT/AST > 2.5 times ULN or > 5 times ULN in case of liver metastasis.
* Inadequate renal function: creatinine clearance <20 ml/min.
* Prior allergy to any vinca-alkaloid.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Local Institution - Liverpool
Recruitment hospital [2] 0 0
Local Institution - Sydney
Recruitment hospital [3] 0 0
Local Institution - Taree
Recruitment hospital [4] 0 0
Local Institution - Waratah
Recruitment hospital [5] 0 0
Local Institution - Westmead
Recruitment hospital [6] 0 0
Local Institution - Adelaide
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Taree
Recruitment postcode(s) [4] 0 0
- Waratah
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
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
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
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
Massachusetts
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United States of America
State/province [12] 0 0
Michigan
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United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Hampshire
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United States of America
State/province [16] 0 0
New York
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United States of America
State/province [17] 0 0
North Carolina
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United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
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United States of America
State/province [20] 0 0
Rhode Island
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United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Austria
State/province [26] 0 0
Salzburg
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Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
France
State/province [30] 0 0
Caen
Country [31] 0 0
France
State/province [31] 0 0
Le Mans Cedex 2
Country [32] 0 0
France
State/province [32] 0 0
Nice
Country [33] 0 0
France
State/province [33] 0 0
Paris
Country [34] 0 0
France
State/province [34] 0 0
Toulouse
Country [35] 0 0
Greece
State/province [35] 0 0
Ilion
Country [36] 0 0
Indonesia
State/province [36] 0 0
Jakarta
Country [37] 0 0
Italy
State/province [37] 0 0
Genova
Country [38] 0 0
Italy
State/province [38] 0 0
Milan
Country [39] 0 0
Italy
State/province [39] 0 0
Roma
Country [40] 0 0
Italy
State/province [40] 0 0
Rome
Country [41] 0 0
Italy
State/province [41] 0 0
Viterbo
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Philippines
State/province [43] 0 0
Cebu City
Country [44] 0 0
Philippines
State/province [44] 0 0
Quezon City
Country [45] 0 0
Philippines
State/province [45] 0 0
Quezon
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Singapore
State/province [46] 0 0
Singapore
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Spain
State/province [47] 0 0
Murcia
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Spain
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Palma De Mallorca
Country [49] 0 0
Spain
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Santander
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Sweden
State/province [51] 0 0
Linkoping
Country [52] 0 0
Sweden
State/province [52] 0 0
Uppsala
Country [53] 0 0
Switzerland
State/province [53] 0 0
Aarau
Country [54] 0 0
Thailand
State/province [54] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pierre Fabre Medicament
Address [1] 0 0
Country [1] 0 0

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/NCT00101608