Conditions: Head and Neck Cancer
Keywords: Head and neck cancer Phase II Locally advanced Squamous Cell Carboplatin Nab-paclitaxel Abraxane Cetuximab Induction Chemotherapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief 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.

Detailed description:
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. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.

Arms:
arm 1: * nab-paclitaxel 100mg/m2
* Carboplatin area under curve (AUC)2 (IV)
* Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks

Interventions: intervention 1: Cetuximab intervention 2: Nab-paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. intervention 2: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. intervention 3: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Protocol document: