Phase-II Study of SU011248 (Sunitinib)in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer
The purpose of this study is to investigate the activity of SU011248 in subjects with cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248 treatment may prove to increase disease response.
Relapsed or Cisplatin-Refractory Germ Cell Cancer
Drug: SU011248 (Sunitinib)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Open-Labeled Non Randomised Phase-II Study of SU011248 (Sunitinib) in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer - A CUOG / GTCSG Cooperative Phase II Study -|
- Response Rate
- Rate and duration of stable disease
- Time to progression.
- Median and 1 yr survival
- Safety and tolerability of SU011248
|Study Start Date:||November 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
SU011248 is a new investigational drug that has been shown to be effective against kidney cancer and other cancers in clinical trials. An investigational drug in Canada is a drug that is not yet approved for standard treatment. SU011248 inhibits enzymes (chemicals that help cells function) called tyrosine kinases, which are important enzymes for tumor growth and tumor spread in your body. If these enzymes are blocked, tumor growth may be disrupted and subsequently the cancer cell may die. SU011248 has been given to patients with kidney cancer and other cancers in clinical trials and some of them have improved, although it is not yet certain how often this occurs. There is some evidence that the enzymes inhibited by SU011248 also play an important role in the development and growth of germ cell cancers. This is the reason why SU011248 is being tested in subjects with germ cell cancers.
To assess the response rate of SU011248 in patients with relapsed or cisplatin- refractory germ cell cancer.
Secondary: To assess the rate of disease stabilizations, toxicity, time to progression and response duration of SU011248 given to patients with relapsed or cisplatin-refractory germ cell cancer.
Study Drug Regimen:
SU011248 will be given at 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks. SU011248 will be orally self-administered once daily without regard to meals. Patients will remain on the study drug until disease progression.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T4N 4N2|
|Canada, British Columbia|
|BC Cancer Agency - Vancouver Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Cancer Care Manitoba|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Nova Scotia|
|QEII Health Science Center|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G2M9|
|Principal Investigator:||Christian K Kollmannsberger, MD||BC Cancer Agency -Vancouver Centre|