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A Phase I Study of RAD001 (Everolimus), Docetaxel, and Cisplatin as Induction Chemotherapy for Patients with Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma
[Protocol 09-028]
- Full Title :
- A PHASE I STUDY OF RAD001 (EVEROLIMUS) + DOCETAXEL + CISPLATIN AS INDUCTION CHEMOTHERAPY IN PATIENTS WITH LOCAL-REGIONAL ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC)
- Purpose :
Cisplatin, docetaxel, and 5-fluorouracil are anticancer drugs commonly used to treat head and neck cancers that are not going to be surgically removed. This regimen is called induction chemotherapy and is followed by several weeks of radiation therapy.
In this study, researchers want to determine the highest safe dose of a new drug called RAD001 (everolimus) that can be given with cisplatin and docetaxel in patients with newly diagnosed squamous cell carcinoma of the head and neck that has not spread (metastasized) elsewhere in the body. Everolimus inhibits a molecule called mTOR and has been shown in laboratory studies to improve the ability of cisplatin to kill cancer cells. Everolimus is approved for the treatment of renal cell carcinoma, but its use for head and neck cancers is considered investigational.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of previously untreated stage III-IVB head and neck squamous cell cancer or stage II cancer of the hypopharynx that is not going to be surgically removed.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Matthew G. Fury at 212-639-3049.
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