SPRUCE: SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

Sponsor

AHS Cancer Control Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT00578526

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arms

75.5

Duration (Months)

12.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Actual 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 :

Apr 1, 2008

Actual Primary Completion Date :

Jul 16, 2014

Actual Study Completion Date :

Jul 16, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 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 Names: Sutent, Sunitinib
Placebo Comparator: Arm 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

Arm

Intervention/Treatment

Active Comparator: Arm 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 Names:

Sutent, Sunitinib

Placebo Comparator: Arm 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

Outcome Measures

Primary Outcome Measures

Progression Free Survival [4 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Centre	Calgary	Alberta	Canada	T2N 4N2
2	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
3	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia	Canada	V5Z 4E6
4	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
5	London Health Sciences Centre	London	Ontario	Canada	T6A 4L6