Head and Neck Cancer. Clinical Trial
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.
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment