Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833261
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cetuximab Drug: cisplatin Radiation: intensity-modulated radiation therapy Phase 2

Detailed Description:



  • To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.


  • To determine the progression-free survival and local-regional progression in these patients.
  • To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
  • To determine the pattern of disease progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
Actual Study Start Date : December 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: chemo radiation
Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy
Drug: cetuximab
Other Name: chemo

Drug: cisplatin
Other Name: chemo

Radiation: intensity-modulated radiation therapy
Other Name: IMRT

Primary Outcome Measures :
  1. crude survival [ Time Frame: one year ]
    1-year crude survival

Secondary Outcome Measures :
  1. progression-free survival and local-regional progression [ Time Frame: 1 year ]
    1-year progression-free survival and local-regional progression

  2. acute and late toxicities [ Time Frame: 6 month ]
    Incidence rate of acute and late toxicities

  3. disease progression [ Time Frame: 1 year ]
    Pattern of disease progression

  4. Response [ Time Frame: 2 years ]
    tumor response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract
  • Recurrent disease or second primary SCC

    • Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)
    • Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy
    • More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy
  • Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)

    • No signs of carotid exposure
  • No primary nasopharyngeal or salivary gland tumor
  • Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan
  • No distant metastasis


  • Karnofsky performance status 70-100%
  • ANC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Bilirubin < 1.5 mg/dL
  • AST or ALT < 2 times upper limit of normal
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded
  • No active cardiac disease, including any of the following:

    • Unstable angina
    • Uncontrolled hypertension
    • Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
    • Uncontrolled arrhythmia
    • Congestive heart failure
    • At least 3 heart-related hospitalizations within the past year
  • No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
  • No concurrent medical illness that would impair patient tolerance to therapy or limit survival
  • No other invasive malignancy within the past 2 years
  • No pre-existing peripheral sensory neuropathy ≥ grade 2
  • No prior severe infusion reaction to a monoclonal antibody
  • No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness


  • See Disease Characteristics
  • Recovered from prior surgery
  • Prior cisplatin and cetuximab allowed
  • At least 6 months since prior radiotherapy or chemotherapy
  • No prior radiotherapy > 75 Gy
  • No prior chemotherapy for recurrent head and neck cancer

    • Prior chemotherapy as a component of the primary treatment allowed
  • No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer

    • Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00833261

United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75204
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Lucien A. Nedzi, MD Simmons Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT00833261     History of Changes
Other Study ID Numbers: CDR0000632295
CA 225314
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Keywords provided by University of Texas Southwestern Medical Center:
recurrent hypopharynx Cancer
recurrent larynx Cancer
recurrent verrucous carcinoma
squamous cell carcinoma
recurrent oral cavity cancer
recurrent metastatic occult primary cancer
recurrent oropharynx cacner
recurrent paranasal sinus and nasal cavity cancer
tongue cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents