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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

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Trial Conditions
  • Head and Neck Cancer
What is the purpose of this trial?

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- 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)

- Aspartate aminotransferase (AST) or alanine aminotransferase (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

Gender: Both
Steward Physician(s)
  • Paul M. Harari, MD
  • Merrill S. Kies, MD
  • Jeffrey N. Myers, MD, PhD, FACS
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
  • cetuximab
  • cisplatin
  • docetaxel
  • adjuvant therapy
  • radiation therapy
Physician Researcher

Investigator Name:

  • Paul M. Harari, MD
  • Merrill S. Kies, MD
  • Jeffrey N. Myers, MD, PhD, FACS

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00084318
Volunteers:  Not Accepting Healthy Volunteers

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