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.
| Verified date | December 2005 |
| Source | University of Maryland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | April 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Maryland | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| University of Maryland | MedImmune LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | |||
| Secondary | 2. To determine the response rate of this regimen in the population. |