drugset / Trial / NCT00629226

Bortezomib, Cetuximab, and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage IV Head and Neck Cancer

NCT00629226 ↗

Phase 1 Completed 46 enrolled National Cancer Institute (NCI)
Treatment

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. Radiation therapy uses high energy x- rays to kill tumor cells. Bortezomib and cetuximab may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with cetuximab, radiation therapy, and cisplatin 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 and radiation therapy with or without cisplatin in treating patients with stage IV head and neck cancer.

Timeline

Start
2007-10
Primary completion
2010-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule — Intravenous
Subject Cetuximab Monoclonal antibody — Intravenous
Subject Cisplatin Other / unclassified — Intravenous

Indications