Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Conditions
Head and Neck Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
head and neck cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cetuximab Type: Drug
Name: Radiation Therapy Type: Radiation
Overall Status
Recruiting
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.
Detailed Description
This is a Phase II trial to characterize the feasibility of treating patients with locally advanced cutaneous squamous cell carcinomas of the head and neck with post-operative radiotherapy and cetuximab. Cetuximab has previously been given safely in conjunction with head and neck radiotherapy for mucosal squamous cell carcinoma in multiple phase III trials, and so Phase I data is not necessary here.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
Location
University of Cincinnati
Cincinnati, Ohio, United States
Status: Recruiting
Contact: University of Cincinnati Cancer Institute - 513-584-7698
Start Date
October 2013
Completion Date
October 2021
Sponsors
University of Cincinnati
Source
University of Cincinnati
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page