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

NCT ID: NCT00904345

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

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.

50-60 Gy and 70 Gy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shruti Jolly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Medical Center

Ann Arbor, Michigan, United States

University of Michigan Veterans Administration Hospital

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM 27253

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2009.009

Identifier Type: -

Identifier Source: org_study_id

NCT01250522

Identifier Type: -

Identifier Source: nct_alias