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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
364
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local Institution
Brampton, Ontario, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Kingston, Ontario, Canada
Local Institution
London, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
duration of Overall Survival after Randomization
Time frame: 30-March-07
patient benefit
Time frame: 30-Mar-07
safety
Time frame: 30-Mar-2007
response rate
Time frame: throughout the study
time to response
Time frame: upon occurrence
response duration
Time frame: throughout the study
progression free survival
Time frame: throughout the study
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