A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
This study involves two phases. Phase I of this study is designed to find out the maximum
dose of paclitaxel poliglumex which can be safely given to subjects when combined with
cetuximab and radiotherapy in head and neck cancer. Once the maximum safe dose of paclitaxel
poliglumex is found, Phase II of the study will continue to find out whether the addition of
paclitaxel poliglumex increases tumor response and survival compared to treatment with
cetuximab and radiotherapy alone.
An additional 20 patients have been added, to balance data. These patients must be HPV
negative.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
State University of New York - Upstate Medical University