AlteRCC phase I-II trial: Alternating radiotherapy and chemotherapy plus cetuximab in advanced head and neck cancer (HNC)

15515 Background: Pfister (ASCO 2003) added Cetuximab (C) to CT/RT to evaluate toxicity and activity of this combination in advanced HNC. The trial was early stopped due to an excess of toxicity including on treatment deaths. However, the treated pts achieved an excellent long term. Results: 76% of them were alive and disease free at 24 months. Therefore, a new, less toxic scheduling of CT/RT and C is highly attractive. Alternating CT/RT (ACR) may be less toxic than concurrent CT/RT (Haffty 2000; Merlano 2003). Therefore we designed a phase I-II trial, scheduling finding, combining ACR and C. Methods: The ACR regimen consists of cisplatin 20 mg/m2 and 5FU 200 mg/m2 days 1 to 5, weeks 1, 4 and 7; and RT, 2 Gy/day, days 1 to 5, weeks 2–3, 5–6, 8–10 to a total dose of 66 Gy. ACR remains unchanged during both phase I and phase II part of the study, whereas C is given to the first 6 pts (phase I, step I) weekly only in the weeks when RT is delivered. If no limiting toxicity is observed, C is combined also with...