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Phase II Study of Amifostine in Alleviating Toxicity Associated with Targeted Supradose Cisplatin and Concurrent Radiotherapy in Patients with Stage III or IV Squamous Cell Carcinoma of the Head and Neck

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Supportive care, Treatment Completed 18 and over Pharmaceutical / Industry UTENN-6507
ALZA-98-066-ii, NCI-V98-1472, NCT00003580

Objectives

I.  Determine the efficacy of amifostine in alleviating treatment related 
mucositis associated with targeted supradose cisplatin and concurrent 
radiotherapy (RADPLAT protocol) in patients with stage III or IV squamous cell 
carcinoma of the head and neck.

II.  Determine the efficacy of amifostine in alleviating other treatment 
related morbidities associated with this protocol in these patients.

Entry Criteria

Disease Characteristics:


Histologically confirmed squamous cell carcinoma of the oral cavity,
nasopharynx, oropharynx, hypopharynx, or larynx
 Previously untreated 
 Stage III or IV 

No distant metastatic disease

Prior/Concurrent Therapy:


No prior therapy for head and neck cancer

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 At least 24 hours since prior antihypertensive medication

Patient Characteristics:


Age:
 18 and over

Performance status:
 Karnofsky 60-100%

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 3,500/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal:
 Creatinine no greater than 2.0 mg/dL
 Creatinine clearance greater than 61 mL/min

Other:
 No history of any underlying medical or psychiatric illness
 Not pregnant or nursing
 Effective contraception required of all fertile patients

Expected Enrollment

Approximately 30 patients will be accrued into this study over 12-18 months.

Outline

This is an open label, multicenter study of amifostine.

Patients receive external beam radiotherapy 5 days a week for approximately 
6.5-7.5 weeks.  Concurrent with radiotherapy, patients receive amifostine IV 
over 10 minutes, 30 minutes prior to cisplatin, then cisplatin 
intra-arterially over 3-5 minutes.  Chemotherapy and amifostine course is 
repeated every week for 4 weeks. 

Patients are followed at 1 month.

Trial Contact Information

Trial Lead Organizations

UT Bowld Hospital

K. Thomas Robbins, MD, Protocol chair(Contact information may not be current)
Ph: 352-392-4461

Registry Information

Official Title		Phase II Study - Efficacy of Amifostine in Alleviating Toxicity Associated with Targeted Supradose Cisplatin and Concomitant Radiation Therapy (RADPLAT) in Head and Neck Cancer

Trial Start Date		1998-06-01

Registered in ClinicalTrials.gov		NCT00003580

Date Submitted to PDQ		1998-09-14

Information Last Verified		2006-05-18

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.