SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

AHS Cancer Control Alberta64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Urothelial Cancer Bladder Cancer Adult

Interventions

SU011248DRUG

50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression

PlaceboDRUG

50 mg capsule OD PO for 28 days then 14 days rest until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: 4 months

Secondary Outcomes

objective response rate

Time frame: Study Duration

duration of response

Time frame: study duration

Change in health-related quality of life

Time frame: Study Duration

Number of participants that develop an adverse event to treatment.

Time frame: Study Duration

Overall Survival

Time frame: Study Duration

Data from ClinicalTrials.gov

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