A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- 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
- 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 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:
- ANC > or = 1,500/mm3
- Platelets > or = 100,000/mm3
- HgB > 9g/dL
- Total bilirubin < or = 1.5mg/dL
- Albumin > 2.5 g/dL
- AST(SGOT)/ALT(SGPT) < or = 2.5X institutional upper limit of normal, alkaline
phosphatase < 2.5 x upper limit of normal, 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 IgE antibodies to
- 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).