Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer
This is a study for patients who have head and neck cancer that has recurred in the body area where they previously received radiation, and for whom surgery is not planned. A widely accepted treatment option in this situation is chemotherapy alone. Another approach that has been used in clinical trials is to treat patients with a repeat course of radiation. In these studies, some patients received chemotherapy at the same time as the radiation.
In this clinical study, we wish to treat with radiation plus two drugs during the course of reirradiation, Taxotere® (docetaxel) and Erbitux® (cetuximab). Docetaxel and cetuximab both are chemotherapy drugs which are administered by vein. Both drugs help radiation kill cancer cells.
The radiation will be administered using a strategy called intensity-modulated radiation therapy (IMRT), which focuses the radiation beam on the tumor.
Docetaxel and cetuximab are both approved for the treatment of patients with head and neck cancer.
However, the combination of radiation + docetaxel + cetuximab for patients with recurrent head and neck cancer is considered to be a topic for clinical research. The purpose of this study is to determine the good and bad effects of treatment with radiation + docetaxel + cetuximab.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity -Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer|
- The primary endpoint is 2-year progression-free survival (PFS). [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- To evaluate the safety and tolerability of re-irradiation + docetaxel + cetuximab for patients with locoregionally recurrent head and neck cancer. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- To estimate median overall survival for this patient population. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- To estimate 2-year locoregional control for this patient population. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Radiation: IMRT, cetuximab, docetaxel
IMRT will be administered in once daily fractions (2 Gy/day, Monday through Friday) over approximately 7 weeks to a goal of approximately 70 Gy. The chemotherapy regimen will begin with a loading dose of intravenous cetuximab (400 mg/m2) one week prior to the initiation of radiation therapy, followed by weekly administration of intravenous docetaxel (15 mg/m2) and intravenous cetuximab (250 mg/m2) for approximately 7 weeks concurrently with radiation. Patients will be evaluated weekly prior to their chemotherapy. All patients will be evaluated on an intention-to-treat basis.
|United States, Nebraska|
|Omaha, Nebraska, United States, 68114|
|United States, New Jersey|
|Memorial Sloan-Kettering Cancer Center at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07939|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Matthew Fury, MD, PhD||Memorial Sloan-Kettering Cancer Center|