A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
18 Years
N/A
Both
Urothelial Cancer, Bladder Cancer, Adult
Trial Information
A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Tina Cheng, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Tom Baker Cancer Centre
Authority:
Canada: Health Canada
Study ID:
SPRUCE02
NCT ID:
NCT00578526
Start Date:
April 2008
Completion Date:
Related Keywords:
- Urothelial Cancer
- Bladder Cancer
- Adult
- urothelial cancer
- targeted therapy
- antiangiogenesis therapy
- SU011248
- clinical trial
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
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