Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer

Summary

Background: Bortezomib acts on molecules in head and neck cancer cells that are important for the cells growth and survival. The drug may help make the cancer more sensitive to radiation and other chemotherapy drugs. Cetuximab is a monoclonal antibody that has increased the effectiveness of radiation treatment in patients with head and neck cancer in clinical trials. Cisplatin has shrunk head and neck cancers and improved treatment response and survival when combined with radiation treatment. Objectives: To determine the highest safe dose of bortezomib when combined with cetuximab without or with cisplatin and with radiation in patients with advanced head and neck cancer. To examine the benefits and side effects of these drug combinations with radiation in patients with advanced head and neck cancer. Eligibility: Patients 18 years of age and older with advanced Stage IV head and neck cancer who have not previously had neck radiation. Design: Patients will be assigned sequentially to one of two treatment groups: Group A receives bortezomib and cetuximab beginning the week before, and for the duration of, radiation therapy; Group B receives bortezomib, cetuximab and cisplatin beginning the week before, and for the duration of, radiation therapy. * Cetuximab is given as a 2-hour infusion through a vein (intravenously, IV) for the first dose and then over 1 hour for subsequent weekly doses. * Bortezomib is given as an injection into a vein over about 5 seconds, twice a week for 2 weeks, followed by a 1-week rest for a total of three 3-week treatment cycles during radiation. * Cisplatin is given in once a week as a 1-hour IV infusion * Radiation therapy is given 5 days a week for 7 to 8 weeks. Post-treatment follow-up: * Until 2 weeks after treatment ends, patients are followed once a week including a physical examination, review of treatment side effects, and blood tests. * For 2 months after treatment ends, patients may need to return to the hospital for medical evaluation and supportive care, depending on their condition. * 8-weeks after treatment ends, patients return for evaluation with a history and physical examination; blood tests; ear, nose and throat evaluation and endoscopy; CT or MRI scan, or both, of the neck and chest; and, if indicated, a PET scan....

Timeline

Start

2008-02-05

Primary completion

2010-08-27

Completion

2010-08-27

Publications

• Background Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.
• Background Kotwall C, Sako K, Razack MS, Rao U, Bakamjian V, Shedd DP. Metastatic patterns in squamous cell cancer of the head and neck. Am J Surg. 1987 Oct;154(4):439-42. doi: 10.1016/0002-9610(89)90020-2.
• Background Hong WK, Lippman SM, Itri LM, Karp DD, Lee JS, Byers RM, Schantz SP, Kramer AM, Lotan R, Peters LJ, et al. Prevention of second primary tumors with isotretinoin in squamous-cell carcinoma of the head and neck. N Engl J Med. 1990 Sep 20;323(12):795-801. doi: 10.1056/NEJM199009203231205.

Drugs

Indications