Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Head and Neck Cancer; Oral Complications of Cancer and Cancer Therapy; Radiation Toxicity
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); radiation therapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: UT Bowld Hospital Official(s) and/or principal investigator(s):
K. Thomas Robbins, MD, Study Chair, Affiliation: University of Florida
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy
and radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating side effects of
treatment in patients receiving radiation therapy and cisplatin for advanced head and neck
cancer.
Clinical Details
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
Study design: Supportive Care
Detailed description:
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.
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.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued into this study over 12-18
months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
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
Locations and Contacts
William F. Bowld Hospital, Memphis, Tennessee 38103, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1998
Last updated: June 17, 2008
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