Clinical trial NCT00578526: SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urothelial Cancer
Bladder Cancer
Adult
Keywords: urothelial cancer
targeted therapy
antiangiogenesis therapy
SU011248
clinical trial
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-12-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 4 months
Secondary outcomes:
measure: objective response rate
timeFrame: Study Duration
measure: duration of response
timeFrame: study duration
measure: Change in health-related quality of life
timeFrame: Study Duration
measure: Number of participants that develop an adverse event to treatment.
timeFrame: Study Duration
measure: Overall Survival
timeFrame: Study Duration
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Tom Baker Cancer Centre
name: Tina Cheng, M.D.
role: STUDY_DIRECTOR
References: