Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Nab-paclitaxel; Carboplatin
Intervention description: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.; Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.; Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Intervention MeSH terms: Paclitaxel; Carboplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and neck cancer; Phase II; Locally advanced; Squamous Cell; Carboplatin; Nab-paclitaxel; Abraxane; Cetuximab; Induction; Chemotherapy

Summary:

      This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head
      and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged
      appropriate for non-surgical definitive therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed SCCHN or poorly differentiated or
             undifferentiated cancer of the head and neck.

          -  Measurable disease.

          -  All primary sites are eligible excluding nasopharyngeal.

          -  Surgically unresectable and/or N2b or greater nodal disease; Note: surgical
             unresectability will be defined as the combination of the treating surgeon's judgment
             of unresectability plus one of the following objective criteria:

               -  Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid
                  artery.

               -  Involvement of prevertebral musculature

               -  Invasion of the bone of the skull base

               -  Need for glossectomy or extensive glossal resection where functional outcome is
                  considered unacceptable to surgeon or patient

               -  Involvement of the cervical spine

               -  Severe, unacceptable functional deficit that would result from any proposed
                  definitive surgical resection.

          -  ECOG performance status 0-1

          -  Prior therapy:

               -  Chemotherapy: No prior chemotherapy for the treatment of SCCHN.

               -  Platinum chemotherapy: No previous history of carboplatin or cisplatin therapy.

               -  Nab-paclitaxel: No previous treatment with nab-paclitaxel or another taxane.

               -  Cetuximab: No previous treatment with cetuximab Or another epidermal growth
                  factor receptor (EGFR) inhibitor.

               -  Radiation therapy: No prior radiation to the head and neck region.

          -  Age > or = 18 years. Men and women are eligible for participation.

          -  Must have acceptable organ and marrow function as defined below. Laboratory tests
             should be completed within 14 days prior to registration:

               -  Absolute Neutrophil Count (ANC) > or = 1,500/mm3

               -  Platelets > or = 100,000/mm3

               -  Hemoglobin (Hgb) > 9g/dL

               -  Total bilirubin < or = 1.5mg/dL

               -  Albumin > 2.5 g/dL

               -  Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) < or = 2.5 times
                  institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of
                  normal, glomerular filtration rate (GFR) > 30 mL/min (by standard Cockcroft and
                  Gault formula or measured via 24 hour urine collection)

          -  No pre-existing neuropathy greater than grade I

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             performed within 7 days prior to day 1 of study treatment.

          -  Women of childbearing potential and men must agree to use adequate contraception prior
             to study entry, for the duration of study participation and for three months after
             completing treatment. Adequate contraception is defined as any medically recommended
             method (or combination of methods) as per standard of care.

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document.

          -  Patients must have a negative result for preformed immunoglobulin E (IgE) antibodies
             to galactose-alpha-1,3,-galactose.

        Exclusion Criteria:

          -  Prior treatment with any of the study medications.

          -  Prior radiation to any of the field required to treat the tumor.

          -  Any metastatic disease.

          -  The patient may have had a prior malignancy but must be disease-free for three years
             prior to study entry. A history of superficial non-melanoma skin cancer or in situ
             carcinoma of the cervix less than three years will be allowed.

          -  Pregnant or lactating female

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection requiring IV antibiotics, or psychiatric illness/social situations that
             would limit compliance with study requirements. Cardiac disease such as symptomatic
             congestive heart failure, unstable angina pectoris, or myocardial infarction will
             result in exclusion only if active within the past six months. Cardiac dysrhythmia
             will only result in exclusion if active and symptomatic (for example, rate-controlled
             atrial fibrillation will not result in exclusion).