A Phase I/IIB Study of Combination Weekly Carboplatin, Cetuximab and Dose Escalation of RAD001 in Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Status
Active
Cancer Type
Oral Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01283334
Protocol IDs
WCI1761-09 (primary)
Study Sponsor
Winship Cancer Institute of Emory University

Summary

The purpose of this study is to test the drug RAD001in 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.

Treatment Sites in Georgia


Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Study Coordinator:
Stephanie McMillan
404-686-1855

Doctors:

Nabil F. Saba MD, FACP