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

Primary Purpose

Urothelial Cancer, Bladder Cancer, Adult

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
SU011248
Placebo
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Cancer focused on measuring urothelial cancer, targeted therapy, antiangiogenesis therapy, SU011248, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • British Columbia Cancer Agency - Vancouver Centre
  • Juravinski Cancer Centre
  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks

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.

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

objective response rate
duration of response
Change in health-related quality of life
Number of participants that develop an adverse event to treatment.
Overall Survival

Full Information

First Posted
December 19, 2007
Last Updated
August 20, 2018
Sponsor
AHS Cancer Control Alberta
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00578526
Brief Title
SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 16, 2014 (Actual)
Study Completion Date
July 16, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Cancer, Bladder Cancer, Adult
Keywords
urothelial cancer, targeted therapy, antiangiogenesis therapy, SU011248, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
SU011248
Other Intervention Name(s)
Sutent, Sunitinib
Intervention Description
50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 mg capsule OD PO for 28 days then 14 days rest until disease progression
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
4 months
Secondary Outcome Measure Information:
Title
objective response rate
Time Frame
Study Duration
Title
duration of response
Time Frame
study duration
Title
Change in health-related quality of life
Time Frame
Study Duration
Title
Number of participants that develop an adverse event to treatment.
Time Frame
Study Duration
Title
Overall Survival
Time Frame
Study Duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Cheng, M.D.
Organizational Affiliation
Tom Baker Cancer Centre
Official's Role
Study Director
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
T6A 4L6
Country
Canada

12. IPD Sharing Statement

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SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

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