Paclitaxel, carboplatin, and long-term continuous infusion of 5-fluorouracil in the treatment of advanced squamous and other selected carcinomas: results of a Phase II trial.

The purpose of this study was to evaluate the feasibility, toxicity, and efficacy of the combination of paclitaxel, carboplatin, and long-term continuous infusion 5-fluorouracil (5-FU) in the treatment of advanced squamous carcinomas of various primary sites. Patients were eligible for this trial if they had metastatic squamous carcinoma at any site except the lung. In addition, patients with locally advanced squamous carcinoma of the head and neck were eligible, if they were considered unlikely to be cured with combined modality therapy. Sixty patients entered this trial between February 1995 and March 1999; 12 patients (20%) had received 1 previous chemotherapy regimen, whereas 48 patients (80%) were previously untreated. All patients received the following regimen: paclitaxel 200 mg/m(2), 1-hour intravenous infusion, Days 1 and 22; carboplatin area under the concentration-time curve (AUC) 6.0 intravenously, Days 1 and 22; 5-FU 225 mg/m(2)/day, by 24-hour continuous intravenous infusion, Days 1-35. Treatment courses were repeated at 6-week intervals; responding patients continued treatment for a maximum of 4 courses (24 weeks). Thirty-nine of 60 patients treated (65%) had objective responses to this regimen, with 25% complete responses. Twelve patients (22%) remain progression free from 7 to 63 months (median, 35 months) after completion of therapy. Complete responses were observed in squamous carcinomas from various primary sites including head and neck, esophagus, cervix, vagina, anus, and unknown primary. The most frequent Grade 3/4 toxicities observed with this 3-drug regimen included leukopenia (48%), diarrhea (17%), mucositis (28%), and portacath-related events (13%). The combination of paclitaxel, carboplatin, and long-term infusional 5-FU is feasible, well tolerated, and highly efficacious in patients with advanced squamous carcinomas of various primary sites. This regimen merits further investigation. Copyright 2001 American Cancer Society.