A Phase I Trial of Bortezomib and Sunitinib
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety and toxicity of combination therapy with sunitinib and bortezomib [ Time Frame: every week ] [ Designated as safety issue: Yes ]
- Tumor shrinkage [ Time Frame: every 6 weeks while on treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Drug: Sunitinib and Bortezomib
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 cycle.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720148
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||John Kauh, MD||Emory University Winship Cancer Institute|