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

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ClinicalTrials.gov Identifier: NCT00904345
Recruitment Status : Terminated (Stopped early for funding and efficacy reasons.)
First Posted : May 19, 2009
Results First Posted : January 20, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
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 : April 2009
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR) [ Time Frame: At baseline (pre-loading dose) and day 7 post-loading dose ]
    The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.

  2. Mean Change in Tumor Phosphorylated EGFR (pEGFR) [ Time Frame: At baseline (pre-loading dose) and day 7 post-loading dose ]
    The ratio (fold change) of tumor pEGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.

  3. Progression Free Survival Rate [ Time Frame: At 1 and 2 years ]
    Percentage of participants who survived without recurrent disease, from the time of enrollment to 1 and 2 years.

  4. Overall Survival Rate [ Time Frame: At 1 and 2 Years ]
    Percentage of participants alive at 1 and 2 years after enrollment.

  5. Number of Participants With Treatment Related Toxicities [ Time Frame: 3 years ]
    Toxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the total number of incidents outnumbers the number of participants. Toxicities are graded according to the CTCAE v4.


Secondary Outcome Measures :
  1. Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa [ Time Frame: At baseline (pre-loading dose) and day 7 post-loading dose ]
    Normal mucosa EGFR was assessed for comparison with EGFR in tumor sample. The fold change in tumor EGFR level at post-loading dose/pre-loading dose of cetuximab, relative to fold change in normal mucosa EGFR level post-loading dose/pre-loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal EGFR.

  2. Change in Tumor pEGFR Level Relative to pEGFR in Normal Mucosa [ Time Frame: At baseline (pre-loading dose) and day 7 post-loading dose ]
    Normal mucosa pEGFR was assessed for comparison with pEGFR in tumor sample. The fold change in tumor pEGFR level post-loading dose/pre loading dose of cetuximab, relative to fold change in normal mucosa pEGFR level post-loading dose/pre-loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal pEGFR.


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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


Locations
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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 Rogel Cancer Center
Investigators
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Principal Investigator: Shruti Jolly, MD University of Michigan Rogel Cancer Center
  Study Documents (Full-Text)

Documents provided by University of Michigan Rogel Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] May 3, 2018

More Information
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00904345    
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
Results First Posted: January 20, 2021
Last Update Posted: February 24, 2021
Last Verified: February 2021
Keywords provided by University of Michigan Rogel Cancer Center:
SCC Head and Neck Cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
 Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents