Cetuximab in Head and Neck Cancer Patients
Condition: Head and Neck Cancer; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms
Intervention: Cetuximab
Intervention description: Monoclonal antibody against epidermal growth factor receptor (EGFR)
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single site, open label, window of opportunity study
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial is for participants with head and neck squamous cell carcinoma who are
      scheduled to have their tumor surgically removed. The study involves obtaining baseline
      tissue from a clinical biopsy or research biopsy and measurement of circulating tumor cells
      before surgery to determine whether AXL protein expression pre-treatment correlates to
      clinical outcomes (change in tumor size) after two doses of cetuximab. The importance of this
      study is to describe if AXL expression can be used as a biomarker to predict clinical
      response to cetuximab (CTX) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Informed consent: participants must be informed of the investigational nature of the study
        and must be able to sign a written informed consent.

          -  Inclusion criteria for research biopsy (screen)

               -  Participants must have suspected or known clinical presentation of head and neck
                  squamous cell carcinoma or a recurrence of head and neck squamous cell carcinoma
                  after initial therapy. For newly suspected head and neck cancer, the procedure
                  will obtain tissue for both standard of care biopsy and additional tissue for
                  research.

               -  Participants must have sufficient tumor volume (approximately 10 cc) to
                  accommodate at minimum 2-3 core samples for the research biopsy. This will be
                  approximated based on clinical evidence, such as physician visualization or
                  palpitation.

               -  Participants are required to consent to the TSB Biobank protocol (2016-0934) as
                  part of this study.

               -  Surgical management must be the chosen modality for management of the head and
                  neck squamous cell cancer.

                    -  Other therapeutic modalities may follow, but surgery must be the choice for
                       first therapy rendered.

          -  Inclusion criteria for cetuximab treatment:

               -  Participants must have a biopsy proven, squamous cell carcinoma of the head and
                  neck, excluding advanced cutaneous head and neck squamous cell carcinoma.

               -  ECOG performance status £ 1

               -  Women of childbearing potential (WOCP) must not be pregnant (confirmed by a
                  negative urine/serum pregnancy test within 7 days of cetuximab treatment). In
                  addition, a medically acceptable method of birth control must be used such as an
                  oral, implantable, injectable, or transdermal hormonal contraceptive, an
                  intrauterine device (IUD), use of a double barrier method (condoms, sponge,
                  diaphragm, or vaginal ring with spermicidal jellies or cream), or total
                  abstinence during the study participation and for 6 months after last dose of
                  study drug. Women who are postmenopausal for at least 1 year or surgically
                  sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are
                  not considered to be WOCP.

               -  Men who are not surgically or medically sterile must agree to use an acceptable
                  method of contraception. Male participants with female sexual partners who are
                  pregnant, possibly pregnant, or who could become pregnant must agree to use
                  condoms during the study and for 6 months post study drug. Total abstinence for
                  the same study period is an acceptable alternative.

               -  Participants with other concomitant malignancies are allowed to participate on
                  the clinical trial as long as the surgical resection of the head and neck
                  squamous cell carcinoma is clinically indicated.

               -  Participants with metastatic disease are allowed to participate on the clinical
                  as long as the surgical resection of the head and neck squamous cell carcinoma is
                  clinically indicated.

        Exclusion Criteria:

          -  Diagnosis of nasopharyngeal carcinoma, advanced cutaneous squamous cell carcinoma of
             the head & neck, and salivary gland tumors

          -  Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.
             active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable
             safety risks or compromise compliance with the protocol

          -  Prior chemotherapy, radiotherapy, or major surgery within 8 weeks of study enrollment
             or those who have not recovered (to grade ≤ 1 or baseline) from clinically significant
             adverse events due to agents administered more than 8 weeks earlier (alopecia and
             fatigue excluded). Clinical significance to be determined by the study investigator

          -  Prior cetuximab therapy is allowed so long as administered ³ 8 weeks ago.

          -  History of allergic reactions attributed to compounds of chemical or biologic
             composition similar to those of cetuximab

          -  Pregnancy, breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the screening visit through 6 months
             after the last dose of trial treatment

          -  Ongoing or active infection, including active tuberculosis or known infection with the
             human immunodeficiency virus (HIV)

          -  Ongoing treatment with other investigational agents.

          -  Any of the following cardiac conditions:

               -  uncontrolled or poorly-controlled arrhythmia or uncontrolled cardiac
                  insufficiency uncontrolled or poorly-controlled hypertension (>180 mmHg systolic
                  or > 130 mmHg diastolic)

          -  Any of the following conditions:

               -  serious or non-healing wound, ulcer, or bone fracture

               -  history of abdominal fistula, gastrointestinal perforation, or intraabdominal
                  abscess within 28 days of study enrollment

               -  history of cerebrovascular accident (CVA) or transient ischemic attack within 12
                  months prior to study enrollment

               -  history of myocardial infarction, ventricular arrhythmia, stable/unstable angina,
                  symptomatic congestive heart failure, coronary/peripheral artery bypass graft or
                  stenting or other significant cardiac disease within 6 months prior to study
                  enrollment

               -  history of arterial or venous thrombosis/thromboembolic event, including
                  pulmonary embolism within 6 months of study enrollment

               -  any condition requiring the use of immunosuppression, excluding rheumatologic
                  conditions treated with stable doses of corticosteroids

               -  Use of herbal supplements (St. John's Wort, gingko biloba, etc.) within one week
                  of cetuximab treatment