Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

OBJECTIVES:

Primary

• To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

• To determine the progression-free survival and local-regional progression in these patients.
• To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
• To determine the pattern of disease progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

DISEASE CHARACTERISTICS:

• Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract
• Recurrent disease or second primary SCC

• Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)
• Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy
• More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy
• Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)

• No signs of carotid exposure
• No primary nasopharyngeal or salivary gland tumor
• Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan
• No distant metastasis

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%
• ANC ≥ 2,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
• Bilirubin < 1.5 mg/dL
• AST or ALT < 2 times upper limit of normal
• Creatinine clearance ≥ 50 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded
• No active cardiac disease, including any of the following:

• Unstable angina
• Uncontrolled hypertension
• Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
• Uncontrolled arrhythmia
• Congestive heart failure
• At least 3 heart-related hospitalizations within the past year
• No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
• No concurrent medical illness that would impair patient tolerance to therapy or limit survival
• No other invasive malignancy within the past 2 years
• No pre-existing peripheral sensory neuropathy ≥ grade 2
• No prior severe infusion reaction to a monoclonal antibody
• No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior surgery
• Prior cisplatin and cetuximab allowed
• At least 6 months since prior radiotherapy or chemotherapy
• No prior radiotherapy > 75 Gy
• No prior chemotherapy for recurrent head and neck cancer

• Prior chemotherapy as a component of the primary treatment allowed
• No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer

• Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment