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

Completed · Phase 1

Conditions studied: Carcinoma, Squamous, Head and Neck Cancer, Oral Cancer, Laryngeal Cancer, Pharyngeal Cancer

In brief

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....

Key facts

Study ID: NCT01445405
Run by: National Cancer Institute (NCI)
People needed: 3
Starts: 2008-02-05
Expected to finish: 2010-08-27
Last updated by the study team: 2019-12-17

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients with previously untreated nasopharyngeal cancer (any stage) will be excluded, but patients with recurrent nasopharyngeal carcinoma will be eligible.
Prior treatment with radiation to the head and neck, or systemic EGFR inhibitors or bortezomib is not allowed.
Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients may not be receiving any other investigational agents.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, cetuximab, cisplatin or other agents used in study.
Patients with greater than or equal to grade 2 peripheral sensory neuropathy because bortezomib can cause irreversible worsening and a painful type of chemotherapy associated peripheral neuropathy.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because bortezomib, cetuximab and cisplatin have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with bortezomib, cetuximab and cisplatin, breastfeeding should be discontinued if the mother is treated with bortezomib, cetuximab and cisplatin. These potential risks may also apply to other agents used in this study.
HIV-positive patients or patients on any antiretroviral therapy are ineligible because of the potential for possible pharmacodynamic interactions with bortezomib, cetuximab and cisplatin, particularly bone marrow and mucosal toxicity, which could affect the MTD. These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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