Phase IB Dose Escalation Study of Bortezomib (VELCADE) Administered Weekly for 4 Weeks and Sunitinib (SU-011248) Administered Daily for 4 Weeks Followed by a 14 Day Rest in Patients With Refractory Solid Tumors
This is a Phase I study assessing the combination of bortezomib and sunitinib in patients
with solid tumors that are refractory to standard chemotherapy.
The study will take place in two stages. In both stages, patients will receive sunitinib
orally with food once daily for 4 weeks and bortezomib by injection into a vein once a week
for 4 weeks. This will be followed by 2 weeks of rest. This 6-week period is called one
In stage 1, a maximum of 10 patients will be treated sequentially with increasing doses of
sunitinib (and a fixed dose of bortezomib). Each dose level must be well tolerated for the
next patient to start treatment at the next dose level. Whichever is the highest dose of
sunitinib that is well tolerated will then be used for the next stage.
In stage 2, a maximum of 20 patients will be treated sequentially with increasing doses of
bortezomib (and a fixed dose of sunitinib). Each dose level must be well tolerated for the
next patient to start treatment at the next dose level.
Together, the two stages will determine the highest doses of both sunitinib and bortezomib
that are well tolerated when given this combination. Determining these optimal doses is the
primary aim of this study. Patients will also be followed to see whether their tumor
responds to the treatment.
If a patient's cancer remains stable or improves, they can repeat the treatment cycles.
There is no defined end date to this study since patients will be followed for the duration
of their survival.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and toxicity of combination therapy with sunitinib and bortezomib
John Kauh, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|