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Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)

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.
ClinicalTrials.gov Identifier: NCT00904345
Recruitment Status : Active, not recruiting
First Posted : May 19, 2009
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Cetuximab Radiation: 50-60 Gy and 70 Gy Phase 2

Detailed Description:

Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.

Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.

Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.

Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.

Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities
Study Start Date : February 2009
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment Drug: Cetuximab
Patients will receive a single dose of cetuximab 400 mg/m (Day 0). On day 7 (+/- 1 day), a repeat biopsy will be performed. Radiation concurrent with weekly cetuximab 250 mg/m.
Radiation: 50-60 Gy and 70 Gy
Within approximately 4 days (after single dose of Cetuximab), definitive radiation will begin (70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes) concurrent with weekly cetuximab 250 mg/m.

Outcome Measures

Primary Outcome Measures :
  1. Mean change in tumor EGFR [ Time Frame: 2 Years ]
    Determine changes in tumor EGFR (epidermal growth factor receptor), pEGFR, following a loading dose of cetuximab in patients who are poor candidates for chemoradiation.

  2. Progression free survival [ Time Frame: 2 Years ]
  3. Overall survival [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. Change in tumor EGFR level relative to EGFR in normal mucosa [ Time Frame: 2 Years ]
    Conduct normal mucosa EGFR assessment for comparison w/ tumor sample. This will be evaluated by means of evaluated by means of repeated measures ANOVA.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.
  • Patients will be limited to:

    • ≥ 70 years of age, OR
    • with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR
    • KPS ≤ 80, OR
    • Creatinine clearance < 30 cc/min
  • Laboratory criteria:

    • WBC > 3500/ul
    • Granulocyte > 1500/ul
    • Platelet count > 100,000/ul
    • Total Bilirubin < 1.5 X ULN
    • AST and ALT < 2.5 X ULN
  • Patients must give documented informed consent to participate in this study.

Exclusion Criteria:

  • Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
  • Prior head and neck radiation or chemotherapy.
  • Documented evidence of distant metastases.
  • Patients with nasopharyngeal carcinoma.
  • Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.
  • Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
  • Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).
  • Patients residing in prison.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00904345

United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
University of Michigan Veterans Administration Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Shruti Jolly, MD University of Michigan Cancer Center
More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00904345     History of Changes
Obsolete Identifiers: NCT01250522
Other Study ID Numbers: UMCC 2009.009
HUM 27253 ( Other Identifier: University of Michigan Medical IRB )
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by University of Michigan Cancer Center:
SCC Head and Neck Cancer

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