Status:
COMPLETED
EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)
Lead Sponsor:
Mohan Suntharalingam
Collaborating Sponsors:
MedImmune LLC
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 trea...
Detailed Description
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 overw...
Eligibility Criteria
Inclusion
- 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.
- Karnofsky performance status of 70% or better at screen and on first day of treatment.
- Patients with loco-regional recurrences from any site with no prior radiation therapy and not amenable for salvage surgery are eligible for study.
- No evidence of distant metastatic disease.
- No previous radiation therapy
- No previous chemotherapy.
- 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
- Evidence of measurable disease.
- No evidence of concomitant malignancy except for non-melanomatous skin cancer (controlled or controllable) or carcinoma in situ of the cervix.
- Signed informed consent.
- No concomitant life threatening or uncontrolled serious medical illness such as end stage congestive heart failure cardiac arrythmia, liver disease and organic brain syndrome.
- Age 18 years or older.
Exclusion
- Preexisting clinically significant neuropathy.
- Patients currently taking antiarrhythmic medications are excluded.
- History of poorly-controlled hypertension, angina, arrhythmias, or a history within the past 6 months of myocardial infarction or acute congestive heart failure.
- Requirement for concurrent use of pilocarpine.
- Treatment with any investigational drugs within 4 weeks of study entry.
- Pregnant or lactating females or females of child bearing potential not employing adequate contraception.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00270790
Start Date
May 1 2002
End Date
February 1 2009
Last Update
February 1 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland
Baltimore, Maryland, United States, 21201