Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

NCT01979211 | Completed Phase 2 Results DMC

• 1 other identifier: UCHN-12-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer. The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Local Regional Control

  The primary endpoint of this study was 2-year locoregional control (LRC), defined as no evidence of recurrent cancer in the tumor bed and/or neck as assessed via clinical exam and imaging. Locoregional control was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who had LRC) and the time for them to be censored.

  2 years

Secondary Outcomes (2)

• Percentage of Participants With Disease-free Survival

  2 years

• Percentage of Participants With Overall Survival

  5 years

Study Arms (1)

Cetuximab and Radiation

EXPERIMENTAL

Cetuximab 400 mg/m2 IV over 120 minutes loading dose \> 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions

Drug: Cetuximab; Radiation: Radiation Therapy

Interventions

Cetuximab DRUG

400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7

Also known as: Erbitux

Cetuximab and Radiation

Radiation Therapy RADIATION

Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab

Cetuximab and Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma of the head and neck
• Clinical stage \>/= T3 or \>/= N1, M0 including no distant metastases
• Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration
• Performance status of 0-1 within 2 weeks prior to registration
• Age \>/= 18
• Adequate labs within 2 weeks prior to registration

You may not qualify if:

• Prior invasive malignancy unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago. Patients with a history of T1-2, N0, M0 resected differentiated thyroid carcinoma are considered eligible.
• Prior systemic chemotherapy or anti-epidermal growth factor therapy for the study cancer or for a different prior cancer
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Results Point of Contact

• Title: Vinita Takiar, Associate Professor, MD
• Organization: University of Cincinnati Cancer Center

vinita.takiar@uc.edu

513-584-4775

Study Officials

• Vinita Takiar, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 8, 2013
• Study Start: October 1, 2013
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: February 29, 2024
• Results First Posted: May 10, 2022

Record last verified: 2024-02

Locations

US (1)