A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer

Summary

The purpose of this study is to test the drug RAD001 in combination with other chemotherapy drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination. The investigators will test the safety of RAD001 in combination with Carboplatin and Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin and Cetuximab will not be varied as both these drugs are considered to be part of the current standard of care for patients with your condition.

Timeline

Start

2011-01

Primary completion

2013-11

Completion

2014-11

Publications

• Results Saba NF, Hurwitz SJ, Magliocca K, Kim S, Owonikoko TK, Harvey D, Ramalingam SS, Chen Z, Rogerio J, Mendel J, Kono SA, Lewis C, Chen AY, Higgins K, El-Deiry M, Wadsworth T, Beitler JJ, Shin DM, Sun SY, Khuri FR. Phase 1 and pharmacokinetic study of everolimus in combination with cetuximab and carboplatin for recurrent/metastatic squamous cell carcinoma of the head and neck. Cancer. 2014 Dec 15;120(24):3940-51. doi: 10.1002/cncr.28965. Epub 2014 Aug 7.

Drugs

Indications