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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer.

Thank you

Trial Information

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.


Inclusion Criteria:



1. 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.

2. Karnofsky performance status of 70% or better at screen and on first day of
treatment.

3. Patients with loco-regional recurrences from any site with no prior radiation therapy
and not amenable for salvage surgery are eligible for study.

4. No evidence of distant metastatic disease.

5. No previous radiation therapy

6. No previous chemotherapy.

7. 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

8. Evidence of measurable disease.

9. No evidence of concomitant malignancy except for non-melanomatous skin cancer
(controlled or controllable) or carcinoma in situ of the cervix.

10. Signed informed consent.

11. No concomitant life threatening or uncontrolled serious medical illness such as end
stage congestive heart failure cardiac arrythmia, liver disease and organic brain
syndrome.

12. Age 18 years or older.

Exclusion Criteria:

1. Preexisting clinically significant neuropathy.

2. Patients currently taking antiarrhythmic medications are excluded.

3. History of poorly-controlled hypertension, angina, arrhythmias, or a history within
the past 6 months of myocardial infarction or acute congestive heart failure.

4. Requirement for concurrent use of pilocarpine.

5. Treatment with any investigational drugs within 4 weeks of study entry.

6. Pregnant or lactating females or females of child bearing potential not employing
adequate contraception.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate whether the addition of the radioprotector Amifostine can reduce the incidence and severity of mucositis and hematological toxicities caused by chemoradiation.

Principal Investigator

Mohan Suntharalingam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland

Authority:

United States: Food and Drug Administration

Study ID:

GCC 0202

NCT ID:

NCT00270790

Start Date:

May 2002

Completion Date:

April 2007

Related Keywords:

  • Head and Neck Cancer.
  • Head and Neck cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Maryland Baltimore, Maryland  21201