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To determine the response rate, survival and toxicity of infusional cisplatin plus fluorouracil (CF) versus cisplatin plus paclitaxel (CP) in patients with incurable squamous cell cancer of the head and neck, with the hypothesis that CP is superior.

Two hundred eighteen patients with locally advanced, recurrent, or metastatic disease were randomly assigned to CF (cisplatin 100 mg/m² day 1 and fluorouracil 1,000 mg/m²/24 hours by continuous intravenous infusion day 1 through 4) or CP (cisplatin 75 mg/m² day 1 and paclitaxel 175 mg/m² over 3 hours on day 1). Cycles were repeated every 3 weeks until progression or a minimum of 6 cycles with complete response or stable disease. The primary outcome was overall survival. Secondary outcomes included response rate and toxicity.

No significant difference in overall survival or …