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| Sponsor: | Mount Sinai School of Medicine |
|---|---|
| Information provided by: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00462735 |
Purpose
For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Cancer of the Pharynx Cancer of the Larynx Nose Neoplasms Paranasal Sinus Neoplasms Cancer of the Oral Cavity |
Drug: cetuximab Drug: hydroxyurea Drug: fluorouracil Procedure: chemotherapy Procedure: radiotherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Johnny Kao, MD | 212-241-7503 | Johnny.kao@mountsinai.org |
| Contact: Stuart Packer, MD | 212-241-8617 | stuart.packer@Mountsinai.org |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Johnny Kao, MD 212-241-7503 Johnny.kao@mountsinai.org | |
| Contact: Stuart Packer, MD 212-241-8617 stuart.packer@Mountsinai.org | |
| Principal Investigator: | Johnny Kao, MD | Mount Sinai School of Medicine |
More Information
| Study ID Numbers: | GCO 06-1155 |
| Study First Received: | April 18, 2007 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00462735 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cancer of the Nasal Cavity |
|
Antimetabolites Otorhinolaryngologic Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Bone Neoplasms Antineoplastic Agents Paranasal Sinus Neoplasms Paranasal Sinus Diseases Hydroxyurea Hematologic Agents Physiological Effects of Drugs Pharyngeal Neoplasms Bone Diseases Neoplasms by Site |
Respiratory Tract Diseases Musculoskeletal Diseases Therapeutic Uses Laryngeal Diseases Nucleic Acid Synthesis Inhibitors Respiratory Tract Neoplasms Antisickling Agents Otorhinolaryngologic Diseases Cetuximab Enzyme Inhibitors Laryngeal Neoplasms Immunosuppressive Agents Pharyngeal Diseases Pharmacologic Actions Nose Diseases |