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Sponsors and Collaborators: |
University of Maryland MedImmune LLC |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00270790 |
Purpose of this study:
There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses special medications. This study uses two chemotherapy drugs (Taxol and Carboplatin), which are FDA approved for treating head and neck cancers. This treatment combination has been associated with difficulty, pain, or a burning sensation upon swallowing (called esophagitis), and decrease in blood cells (cells in the blood which fight against infection). The purpose of this study is to investigate whether the addition of another drug, Amifostine, can reduce the side effects of current combination treatment (radiation and chemotherapy which is standard of care). The addition of Amifostine is the investigational part of the study. The research study is also looking at the side effects of Amifostine and cancer's growth response to this combination treatment.
Condition | Intervention | Phase |
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Head and Neck Cancer. |
Drug: Amifostine Drug: Carboplatin Drug: Taxol Device: Radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A SINGLE SITE EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CONCURRENT CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH ADVANCED LOCOREGIONAL SQUAMOUS CELL CARCINOMAS OF THE HEAD AND NECK. |
Estimated Enrollment: | 25 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | April 2007 |
Patients presenting with locally advanced squamous cell carcinomas of head and neck (SCCHN) continue to represent a significant therapeutic challenge. The bulk of tumor burden often proves to be overwhelming for conventional radiotherapy. Attempts to improve upon these poor outcomes have led investigators to explore several new strategies, one such being chemoradiation. One of the trials conducted at the University of Maryland with carboplatin and paclitaxel with daily radiation showed 82% CR at the primary site. But the most commonly encountered grade 3 toxicities were mucositis (70%), leukopenia (30%) and 3% grade 4 leukopenia. Amifostine: An organic thiophosphate is radioprotective and has shown to protect experimental animals from lethal doses of radiation. Clinical trials have demonstrated that amifostine can provide protection against the hematological toxicities and mucositis seen with various chemotherapeutic agents. Theoretically, drug interactions between amifostine and chemotherapeutic agents are not likely to occur, due to amifostine¿s rapid clearance from plasma (90% of the drug is cleared within 6 minutes). A promising venue would be the investigation of amifostine¿s role in reducing the toxicities associated with chemoradiation (which is standard of care of treating squamous cell carcinomas of head and neck).
Principal objectives of the study: Primary: To evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of mucositis and hematological toxicities caused by chemoradiation. Secondary: 1.To determine the toxicities of amifostine given in this setting. 2. To determine the response rate of this regimen in the population.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites. The following TNM stages by sites will be eligible.
Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses: T4 N0-3, A,B,C T3 N1-3 A,B,C any T, N3 A,B,C Unknown primary: Tx, N3 A,B,C Note: Only clearly unresectable T4 N0 lesions are eligible for study provided the reasons for unresectability are due to extensive anatomic involvement and are outlined by the surgeon.
Adequate renal & bone marrow function determined by the following laboratory parameters.
WBC 3500/ul or higher Platelet count 100.000/ul or higher Hemoglobin 9.0 g/dl or higher BUN 25 mg/dl or less, and Screatinine 2.0 mg/dl or less Total bilirubin less than 2.0 mg/dl, AST/ALT less than 3 times the ULN Creatinine Clearance 50 cc/min or higher
Exclusion Criteria:
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Mohan Suntharalingam, MD | University of Maryland |
Study ID Numbers: | GCC 0202 |
Study First Received: | December 23, 2005 |
Last Updated: | December 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00270790 |
Health Authority: | United States: Food and Drug Administration |
Head and Neck cancer |
Epidermoid carcinoma Amifostine Paclitaxel Squamous cell carcinoma Head and Neck Neoplasms |
Carcinoma, squamous cell Carboplatin Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Carcinoma |
Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Protective Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |