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| Sponsors and Collaborators: |
Alberta Cancer Board Pfizer |
|---|---|
| Information provided by: | Alberta Cancer Board |
| ClinicalTrials.gov Identifier: | NCT00578526 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Urothelial Cancer Bladder Cancer Adult |
Drug: SU011248 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 64 |
| Study Start Date: | April 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
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
|
|
2: Placebo Comparator
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
|
The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the tosicities and tolerablity of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are interolant 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tina Cheng, M.D. | 403-521-3706 | tinachen@cancerboard.ab.ca |
| Contact: Christine Lazzer, MPH, Bsc | 403-521-3678 | chlazzer@cancerboard.ab.ca |
| Canada, Alberta | |
| Tom Baker Cancer Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Tina Cheng, M.D. 403-521-3706 tinachen@cancerboard.ab.ca | |
| Contact: Christine Lazzer, MPH, BSc 403-521-3678 chlazz@cancerboard.ab.ca | |
| Principal Investigator: Tina Cheng, M.D. | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Scott North, M.D. 780-432-8672 scottnor@cancerboard.ab.ca | |
| Principal Investigator: Scott North, M.D. | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Vancouver Centre | Not yet recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Christian Kollmannsberger, M.D. 604-877-6000 ckollmannsberger@bccancer.bc.ca | |
| Principal Investigator: Christian Kollmansberger, M.D. | |
| Canada, Ontario | |
| Juravinski Cancer Centre | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Contact: Som Mukherjee, M.D. 905-387-9711 ext 64631 som.mukherjee@hrcc.on.ca | |
| Princess Margaret Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, M5G 2m9 | |
| Contact: Srikala Sridhar, M.D. 416-946-2249 srikala,sridhar@uhn.on.ca | |
| Principal Investigator: Srikala Sridar, M.D. | |
| London Health Sciences Centre | Not yet recruiting |
| London, Ontario, Canada, T6A 4L6 | |
| Contact: Eric Winquist, M.D. 519-685-8600 eric.winquist@ihsc.on.ca | |
| Principal Investigator: Eric Winquist, M.D. | |
| Study Director: | Tina Cheng, M.D. | Tom Baker Cancer Centre |
More Information
| Responsible Party: | Tom Baker Cancer Centre ( Dr. Tina Cheng - Medical Oncologist ) |
| Study ID Numbers: | SPRUCE02 |
| Study First Received: | December 19, 2007 |
| Last Updated: | August 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00578526 |
| Health Authority: | Canada: Health Canada |
|
urothelial cancer targeted therapy antiangiogenesis therapy SU011248 clinical trial |
|
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma |
Carcinoma Cisplatin Urologic Diseases Sunitinib Urinary tract neoplasm Neoplasms, Glandular and Epithelial Bladder neoplasm |
|
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |
