Spots Global Cancer Trial Database for Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

Official Title: Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR

Study ID: NCT00622674

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

cetuximab

bortezomib

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: Primary * 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). Secondary * 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.