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

AHS Cancer Control Alberta

Status and phase: Completed; Phase 2

Conditions: Adult; Bladder Cancer; Urothelial Cancer

Treatments: Drug: SU011248; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00578526

SPRUCE02

Details and patient eligibility

About

The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.

Full 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

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

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

Treatment:

Drug: SU011248

Arm 2

Placebo Comparator group

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.

Treatment:

Drug: Placebo