SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Urothelial Cancer, Bladder Cancer, Adult

Intervention / Treatment
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* Drug: SU011248
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks | Drug: SU011248<br>* 50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression<br>* Other names: Sutent, Sunitinib;|
| Placebo Comparator: Arm 2<br>1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment. | Drug: Placebo<br>* 50 mg capsule OD PO for 28 days then 14 days rest until disease progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urothelial cancer, targeted therapy, antiangiogenesis therapy, SU011248, clinical trial