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Phase II Study of Docetaxel Plus Cetuximab and Concurrent Re-Irradiation (Intensity-Modulated Radiation Therapy) for Patients with Locoregionally Recurrent Head and Neck Cancer
[Protocol 08-050]
- Full Title :
- PHASE II STUDY OF DOCETAXEL + CETUXIMAB + CONCURRENT RE-IRRADIATION (INTENSITY - MODULATED RADIATION THERAPY, IMRT) FOR PATIENTS WITH LOCOREGIONALLY RECURRENT HEAD AND NECK CANCER
- Purpose :
This is a study for patients with head and neck cancer that has recurred in the part of the body where they previously received radiation therapy . A widely accepted treatment option in this situation is chemotherapy alone if the tumor cannot be removed surgically. Another approach that has been assessed in clinical trials is to treat patients with a repeat course of radiation therapy. In these studies, some patients received chemotherapy at the same time as radiation.
In this clinical study, patients will be treated with radiation plus two drugs during the course of re-irradiation: docetaxel and cetuximab, which are both approved for the treatment of patients with head and neck cancer. Both drugs help radiation kill cancer cells. The radiation therapy will be administered using a strategy called intensity modulated radiation therapy (IMRT), which focuses the radiation beam on the contours of the tumor. Researchers will evaluate the safety and effectiveness of this approach.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have squamous cell carcinoma of the head and neck that has returned in an area that was previously treated with radiation therapy.
- Patients with distant metastatic spread of cancer will not be eligible.
- At least 6 months must have passed since completion of prior radiation therapy and entry into the study.
- Patients may not have had more than two prior regimens of chemotherapy for recurrent disease.
- 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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