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.
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate whether the addition of the radioprotector Amifostine can reduce the incidence and severity of mucositis and hematological toxicities caused by chemoradiation.
Mohan Suntharalingam, MD
Principal Investigator
University of Maryland
United States: Food and Drug Administration
GCC 0202
NCT00270790
May 2002
April 2007
Name | Location |
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University of Maryland | Baltimore, Maryland 21201 |