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
Overview
- Phase
- Phase 2
- Intervention
- SU011248
- Conditions
- Urothelial Cancer
- Sponsor
- AHS Cancer Control Alberta
- Enrollment
- 64
- Locations
- 5
- Primary Endpoint
- Progression Free Survival
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Tina Cheng
Principal Investigator
AHS Cancer Control Alberta
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
Arms & Interventions
Arm 1
SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
Intervention: SU011248
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 4 months
Secondary Outcomes
- 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)
- objective response rate(Study Duration)
- duration of response(study duration)