Adult, Bladder Cancer, Urothelial Cancer
Conditions
Keywords
urothelial cancer, targeted therapy, antiangiogenesis therapy, SU011248, clinical trial
Brief summary
The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
Detailed description
The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy. The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC
Interventions
DRUGSU011248
50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
DRUGPlacebo
50 mg capsule OD PO for 28 days then 14 days rest until disease progression
Sponsors
Pfizer
AHS Cancer Control Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract * Mixed histology with predominant TCC allowed. * Failed, intolerant or ineligible for cisplatin based chemo * Measurable Disease (RECIST)Not previously irradiated. * Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0) * No weight loss \>/- 10% within 28 days of day 0 * Adequate Organ Function
Exclusion criteria
* Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma. * Small cell histology * More than one previous systemic chemo * Excised metastases without remaining measureable disease * Prior therapy with angiogenesis inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate | Study Duration |
| duration of response | study duration |
| Change in health-related quality of life | Study Duration |
| Number of participants that develop an adverse event to treatment. | Study Duration |
| Overall Survival | Study Duration |
Countries
Canada
Outcome results
None listed