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A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck



- Compare disease-free survival of patients with resected stage III or IV squamous cell
carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in
combination with chemoradiotherapy comprising docetaxel vs cisplatin.


- Compare the safety and efficacy of these regimens in these patients.

- Compare locoregional control and overall survival rates in patients treated with these

- Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT,
Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients
treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Zubrod performance status (0 vs 1), risk category (positive margins vs high risk [i.e., ≥ 2
positive nodes or extracapsular nodal extension]) and use of intensity-modulated
radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then
receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on
days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5
days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).

- Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also
receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and
43 (weeks 2-7).

Treatment in both arms continues in the absence of disease progression or unacceptable

Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and
then annually thereafter.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study within approximately 29 months.

Inclusion Criteria


- Histologically confirmed squamous cell carcinoma of the head and neck meeting the
following criteria:

- Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx
(excluding lip, nasopharynx, or sinuses)

- Gross total resection must be completed within 7 weeks of randomization, with
pathology demonstrating one or more of the following risk factors:

- Histologic extracapsular nodal extension

- Histologic involvement of ≥ 2 regional lymph nodes

- Invasive cancer seen on microscopic evaluation of the resection margin,
with no evidence of gross tumor residual. or lymphoepithelioma of the oral
cavity, oropharynx, larynx, or hypopharynx

- Tonsillar cancer patients who undergo transoral excision of all gross tumor
are eligible provided extracapsular nodal extension or involvement of ≥ 2
regional lymph nodes is histologically confirmed

- Stage III or IV disease after gross total resection completed within the past 7

- No evidence of distant metastases

- No synchronous or concurrent head and neck primary tumors



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 8.0 g/dL


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:

- Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN


- Creatinine ≤ 1.5 mg/dL


- No unstable angina

- No uncontrolled hypertension

- No myocardial infarction within the past 6 months (unless successfully treated with
coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)

- No uncontrolled arrhythmia

- No congestive heart failure

- No more than 2 heart-related hospitalizations within the past year

- No other active cardiac disease


- No more than 2 hospitalizations for chronic obstructive pulmonary disease within the
past year


- No pre-existing peripheral neuropathy ≥ grade 2

- No uncontrolled seizure disorder

- No active neurological disease


- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
polysorbate 80

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

- No other concurrent illness that would preclude study participation

- No concurrent psychiatric illness that would preclude study participation

- No other concurrent physical condition (e.g., infectious disease) that would preclude
study participation

- No prisoners

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study


Biologic therapy

- No prior anti-epidermal growth factor receptor antibody therapy


- More than 3 years since prior cytotoxic chemotherapy

Endocrine therapy

- Not specified


- No prior head and neck radiotherapy

- No concurrent intensity-modulated radiotherapy


- See Disease Characteristics


- No prior tyrosine kinase inhibitor therapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:


Principal Investigator

Paul M. Harari, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



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