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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma of Unknown Primary, Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Andre A. Abitbol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-88191

NCT ID:

NCT00003582

Start Date:

May 1988

Completion Date:

December 1996

Related Keywords:

  • Carcinoma of Unknown Primary
  • Head and Neck Cancer
  • squamous cell carcinoma of unknown primary
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma
  • Head and Neck Neoplasms
  • Neoplasms, Unknown Primary

Name

Location

Sylvester Cancer Center, University of MiamiMiami, Florida  33136