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Sponsors and Collaborators: |
Thomas Jefferson University Genentech |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00405405 |
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer. Parotid Gland, Thyroid Gland and Melanoma Cases Stage IV Head and Neck Caner |
Drug: Erlotinib and bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer |
Estimated Enrollment: | 27 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2010 |
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.
The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jorosali Lavarino, BS | 215-955-8619 | jorosali.lavarino@jeffersonhospital.org |
Contact: Joanne Ciconte, BS | 215-955-8619 | joanne.ciconte@jeffersonhospital.org |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Mitchell Machtay, MD 215-955-6706 mitchell.machtay@jeffersonhospital.org | |
Contact: Rita Axelrod, MD 215-955-8874 rita.axelrod@jefferson.edu |
Principal Investigator: | Mitchell Machtay, MD | Thomas Jefferson University |
Study ID Numbers: | 06C.46 |
Study First Received: | November 29, 2006 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00405405 |
Health Authority: | United States: Food and Drug Administration |
Head and neck cancers |
Erlotinib Head and Neck Neoplasms Bevacizumab Melanoma |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |