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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Oncology/Hematology West Sanofi-Aventis |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00713219 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Radiation: IMRT, cetuximab, docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 39 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CHEMORADIATION
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients may be eligible if they have unresected recurrent disease in the prior radiation field. Patients also may be eligible if they have undergone surgical resection of recurrent disease in the prior radiation field with any of the following poor risk pathologic features:
Exclusion Criteria:
Contact: Matthew Fury, MD, PhD | furym@mskcc.org | |
Contact: David Pfister, MD | pfisterd@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering Cancer Center at Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07939 | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org | |
Principal Investigator: Matthew Fury, MD, PhD | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org | |
Contact: David Pfister, MD pfisterd@mskcc.org | |
Principal Investigator: Matthew Fury, MD, PhD | |
Memorial Sloan-Kettering Cancer Center at Commack | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org | |
Principal Investigator: Matthew Fury, MD, PhD | |
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Recruiting |
Rockville Centre, New York, United States, 11570 | |
Contact: Matthew Fury, MD, PhD | |
Principal Investigator: Matthew Fury, MD, PhD | |
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Recruiting |
Sleepy Hollow, New York, United States, 10591 | |
Contact: Matthew Fury, MD, PhD furym@mskcc.org |
Principal Investigator: | Matthew Fury, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Matthew Fury, MD, PhD ) |
Study ID Numbers: | 08-050 |
Study First Received: | July 9, 2008 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00713219 History of Changes |
Health Authority: | United States: Institutional Review Board |
IMRT cetuximab docetaxel |
Docetaxel Head and Neck Neoplasms Cetuximab Recurrence |
Docetaxel Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Head and Neck Neoplasms Cetuximab Pharmacologic Actions |