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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rachel Syme, Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00578526
First received: December 19, 2007
Last updated: January 18, 2012
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Urothelial Cancer
Bladder Cancer
Adult
 Drug: SU011248
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • objective response rate [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: Study Duration ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: April 2008
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578526

Locations
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
Pfizer
Investigators
Study Director: Tina Cheng, M.D. Tom Baker Cancer Centre
  More Information

No publications provided

Responsible Party: Rachel Syme, Dr. Tina Cheng, Alberta Health Services
ClinicalTrials.gov Identifier: NCT00578526     History of Changes
Other Study ID Numbers: SPRUCE02
Study First Received: December 19, 2007
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
urothelial cancer
targeted therapy
antiangiogenesis therapy
SU011248
clinical trial

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013