Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors
- Determine the maximum tolerated dose (MTD) of bortezomib and celecoxib in patients with
advanced solid tumors.
- Determine the overall pattern of toxicities associated with this combination, including
the emergence of any cumulative toxicities, during multiple courses of this regimen.
- Describe the response rate and duration of response or disease stability during therapy
in the subset of patients with measurable disease.
- Assess changes in plasma/serum sphingosine-1-phosphate, ceramide, and other markers of
the apoptotic pathway before and during therapy.
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 or days 1, 8, 15, 22, and 29 and oral
celecoxib twice daily on days 1-21 or 1-42. Courses repeat every 21 or 42 days in the
absence of disease progression or unacceptable toxicity. Patients are evaluated every 2
courses. Patients achieving complete response (CR) receive 2 additional courses of therapy
Cohorts of 3-6 patients receive escalating doses of bortezomib and celecoxib until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum tolerated dose
Andrew S. Kraft, MD
Medical University of South Carolina
United States: Federal Government
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|