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

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ClinicalTrials.gov 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):

December 19, 2007
December 21, 2007
January 19, 2012
April 2008
Not Provided
Progression Free Survival [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT00578526 on ClinicalTrials.gov Archive Site
  • objective response rate [ Time Frame: Study Duration ]
  • duration of response [ Time Frame: study duration ]
  • Quality of Life [ Time Frame: Study Duration ]
  • Safety [ Time Frame: Study Duration ]
  • Overall Survival [ Time Frame: Study Duration ]
Same as current
Not Provided
Not Provided
SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
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 purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.

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

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Urothelial Cancer
  • Bladder Cancer
  • Adult
  • Drug: SU011248
    50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
    Other Name: Sutent, Sunitinib
  • Drug: Placebo
    50 mg capsule OD PO for 28 days then 14 days rest until disease progression
  • Active Comparator: 1
    SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
    Intervention: Drug: SU011248
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Rachel Syme, Alberta Health Services
Alberta Health Services
Study Director: Tina Cheng, M.D. Tom Baker Cancer Centre
AHS Cancer Control Alberta
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP