Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With 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: Carcinoma of Unknown Primary; Head and Neck Cancer; Quality of Life
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); fluorouracil (Drug); paclitaxel (Drug); quality-of-life assessment (Procedure); radiation therapy (Procedure)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Sylvester Cancer Center Official(s) and/or principal investigator(s):
Andre A. Abitbol, MD, Study Chair, Affiliation: Sylvester Cancer Center
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. Chemoprotective drugs, such as amifostine, may protect normal cells from the side
effects of radiation therapy and chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination
chemotherapy and amifostine in treating patients who have stage II, stage III, or stage IV
head and neck cancer that cannot be surgically removed.
Clinical Details
Official title: Phase I/II Study to Evaluate Combined Hyperfractionated Radiation Therapy and 5-Fluorouracil, Cisplatin and Paclitaxel (Taxol) and Amifostine (WR 2721, Ethyol) in Stage III and IV Inoperable Head and Neck Carcinomas
Study design: Treatment
Detailed description:
OBJECTIVES: I. Assess the impact of amifostine on the acute tolerance of combined
hyperfractionated radiation therapy and fluorouracil, cisplatin, and paclitaxel with
amifostine, in terms of the grade and duration of acute mucositis and dermatitis, and acute
hematologic tolerance in patients with stage III or IV unresectable head and neck carcinoma.
II. Determine the local control and survival associated with this regimen in these patients.
III. Determine the long term chronic toxic effects of this regimen in terms of swallowing
dysfunction, PEG dependency, and xerostomia in these patients. IV. Determine the quality of
life post therapy by assessment of speech and swallowing function in these patients. V.
Determine if radiation dose escalation in patients with treatment interruption achieve an
isoeffect on locoregional control. VI. Determine the safe optimal dose of paclitaxel to be
combined with hyperfractionated radiation therapy, fluorouracil, cisplatin, and amifostine in
these patients. VII. Determine the correlation of p53 chromosome expression on locoregional
control and survival of these patients. VIII. Quantitate tumor volumetrics and correlate with
stage, resectability status, and locoregional control and survival of these patients.
OUTLINE: This is a dose escalation of paclitaxel, multicenter study. Patients are stratified
by performance status, stage, institution, tumor volumetrics, resectability, and p53
expression. Patients receive amifostine IV over 10 minutes on Monday of weeks 1, 5, and 9,
and over 5-7 minutes Tuesday through Friday of weeks 1, 5, and 9 and Monday through Friday of
weeks 2, 3, 4, 6, and 7. Within 10-15 minutes of amifostine administration, patients receive
paclitaxel IV over 3 hours, cisplatin IV over 2 hours on days 1, 29, and 56, and fluorouracil
IV over 72 hours on days 1-4, 29-33, and 56-60. Starting on day 2, patients receive
hyperfractionated external beam radiotherapy twice daily over 6. 5 weeks, following amifostine
IV over 5-7 minutes Monday through Friday. Cohorts of 6-20 patients each receive escalating
doses of paclitaxel. Quality of life is assessed. Patients are followed monthly for 1 year,
every 2 months for 1 year, every 6 months for 3 years, and then annually thereafter until
death.
PROJECTED ACCRUAL: A minimum of 36 patients will be accrued for this study within 20 months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and
neck, including: Stage III or IV: oral cavity, paranasal sinus, hypopharynx, oropharynx,
larynx, and nasopharynx OR Unknown primary carcinoma of the head and neck with greater than
N1 disease if no planned neck dissection Evaluable disease No metastases below clavicle by
clinical or radiographic diagnosis All hypopharynx and nasopharynx patients with N3 disease
undergo a CT scan of the chest
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Platelet count at least 130,000/mm3 WBC at least 3,400/mm3
Hemoglobin greater than 10. 0 g/dL (transfusion allowed) Hepatic: Not specified Renal:
Creatinine no greater than 1. 4 mg/dL Cardiovascular: No active heart disease No myocardial
infarction within past 6 months No uncontrolled congestive heart failure No uncontrolled
angina Cardiac ejection fraction at least 50% by MUGA scan for patients under 65 without
antecedent heart disease, at least 55% for patients over 65 and/or with antecedent heart
disease Pulmonary: FEV greater than 60% of predicted Other: Not pregnant or nursing Fertile
patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the
treatment field Surgery: Eligible for PEG gastrostomy Other: At least 24 hours since prior
antihypertensive and diuretic medications (prior to amifostine and chemotherapy regimens)
Locations and Contacts
Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1998
Last updated: May 23, 2008
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