Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR
- To determine the maximum tolerated dose of bortezomib when given together with
cetuximab in patients with advanced solid tumors expressing epidermal growth factor
- To obtain preliminary information about the anti-tumor activity of bortezomib and
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive bortezomib intravenously (IV) on days 1 and 8 and cetuximab IV over 60-90
minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
After the maximum tolerated dose (MTD) is determined, an additional 10 patients are treated
at the MTD.
After completion of study treatment, patients are followed periodically for up to 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of bortezomib
The standard Phase I design will be used to determine the maximum tolerated dose of bortezomib when given with weekly cetuximab. The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%.
At end of Cycle 1 (Week 3)
Arkadiusz Dudek, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
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