SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial (SPRUCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00578526
Recruitment Status : Unknown
Verified September 2011 by Rachel Syme, Alberta Health Services.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2007
Last Update Posted : January 19, 2012
Information provided by (Responsible Party):
Rachel Syme, Alberta Health Services

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.

Condition or disease Intervention/treatment Phase
Urothelial Cancer Bladder Cancer Adult Drug: SU011248 Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2008

Arm Intervention/treatment
Active Comparator: 1
SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
Drug: SU011248
50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
Other Name: Sutent, Sunitinib

Placebo Comparator: 2
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
50 mg capsule OD PO for 28 days then 14 days rest until disease progression

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. objective response rate [ Time Frame: Study Duration ]
  2. duration of response [ Time Frame: study duration ]
  3. Quality of Life [ Time Frame: Study Duration ]
  4. Safety [ Time Frame: Study Duration ]
  5. Overall Survival [ Time Frame: Study Duration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00578526

Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Health Sciences Centre
London, Ontario, Canada, T6A 4L6
Sponsors and Collaborators
Alberta Health Services
Study Director: Tina Cheng, M.D. Tom Baker Cancer Centre

Responsible Party: Rachel Syme, Dr. Tina Cheng, Alberta Health Services Identifier: NCT00578526     History of Changes
Other Study ID Numbers: SPRUCE02
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: September 2011

Keywords provided by Rachel Syme, Alberta Health Services:
urothelial cancer
targeted therapy
antiangiogenesis therapy
clinical trial

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors