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

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

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
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.
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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
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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.

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 |
Principal Investigator: | Shruti Jolly, MD | University of Michigan Rogel Cancer Center |
Documents provided by University of Michigan Rogel Cancer Center:
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 |
SCC Head and Neck Cancer |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |