Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bortezomib together with cetuximab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab in treating patients with advanced solid tumors.
Head and Neck Cancer
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR|
- Maximum tolerated dose (MTD) of bortezomib [ Time Frame: At end of Cycle 1 (Week 3) ] [ Designated as safety issue: Yes ]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%.
- Disease response as measured by RECIST criteria [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]The best overall response is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration.
|Study Start Date:||November 2005|
|Study Completion Date:||February 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: Bortezomib and Cetuximab
The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2. A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
Other Name: ErbituxDrug: bortezomib
The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.
Other Name: Velcade
- To determine the maximum tolerated dose of bortezomib when given together with cetuximab in patients with advanced solid tumors expressing epidermal growth factor receptor (EGFR).
- To obtain preliminary information about the anti-tumor activity of bortezomib and cetuximab.
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.
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Arkadiusz Dudek, MD||Masonic Cancer Center, University of Minnesota|