Back to resultsPhase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
Primary Purpose
Transitional Cell Carcinoma of the Urothelial Tract, Bladder Cancer, Bladder Neoplasms
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
vinflunine and best supportive care
Sponsored by
About this trial
This is an interventional treatment trial for Transitional Cell Carcinoma of the Urothelial Tract
Eligibility Criteria
Inclusion Criteria: Bladder cancer Progressed after 1st line platinum-chemotherapy >= 18 years old Adequate hematologic, hepatic & renal function Exclusion Criteria: CNS disease Moderate neuropathy More than 1 previous chemotherapy
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
best supportive care for 18 week duration
Outcomes
Primary Outcome Measures
duration of Overall Survival after Randomization
Secondary Outcome Measures
patient benefit
safety
response rate
time to response
response duration
progression free survival
Full Information
NCT ID
NCT00315237
First Posted
April 14, 2006
Last Updated
January 6, 2010
Sponsor
Pierre Fabre Medicament
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00315237
Brief Title
Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
Official Title
Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pierre Fabre Medicament
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transitional Cell Carcinoma of the Urothelial Tract, Bladder Cancer, Bladder Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
364 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Arm Description
best supportive care for 18 week duration
Intervention Type
Drug
Intervention Name(s)
vinflunine and best supportive care
Intervention Description
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
Primary Outcome Measure Information:
Title
duration of Overall Survival after Randomization
Time Frame
30-March-07
Secondary Outcome Measure Information:
Title
patient benefit
Time Frame
30-Mar-07
Title
safety
Time Frame
30-Mar-2007
Title
response rate
Time Frame
throughout the study
Title
time to response
Time Frame
upon occurrence
Title
response duration
Time Frame
throughout the study
Title
progression free survival
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bladder cancer
Progressed after 1st line platinum-chemotherapy
>= 18 years old
Adequate hematologic, hepatic & renal function
Exclusion Criteria:
CNS disease
Moderate neuropathy
More than 1 previous chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Local Institution
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Local Institution
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29562804
Citation
Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.
Results Reference
derived
Learn more about this trial
Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract
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