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 -
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
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
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Christian K Kollmannsberger, MD
BC Cancer Agency -Vancouver Centre
Canada: Health Canada
Testis protocol Version 003