SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

Bladder Cancer Clinical Trial

— SPRUCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578526
• Other study ID #: SPRUCE02
• Status: Completed
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: July 16, 2014

Study information

• Verified date: August 2018
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 16, 2014
• Est. primary completion date: July 16, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult
• Bladder Cancer
• Urinary Bladder Neoplasms
• Urothelial Cancer

Intervention

Drug:
• SU011248
50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
• Placebo
50 mg capsule OD PO for 28 days then 14 days rest until disease progression

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		4 months
Secondary	objective response rate		Study Duration
Secondary	duration of response		study duration
Secondary	Change in health-related quality of life		Study Duration
Secondary	Number of participants that develop an adverse event to treatment.		Study Duration
Secondary	Overall Survival		Study Duration