Bladder Cancer, Bladder Neoplasms, Transitional Cell Carcinoma of the Urothelial Tract
Conditions
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.
Interventions
DRUGvinflunine and best supportive care
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
Sponsors
Bristol-Myers Squibb
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of Overall Survival after Randomization | 30-March-07 |
Secondary
| Measure | Time frame |
|---|---|
| safety | 30-Mar-2007 |
| response rate | throughout the study |
| patient benefit | 30-Mar-07 |
| response duration | throughout the study |
| progression free survival | throughout the study |
| time to response | upon occurrence |
Countries
Canada
Outcome results
None listed