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

BACKGROUND. The purpose of this study was to evaluate the feasibility, toxi city, and efficacy of the combination of paclitaxel, carboplatin, and long- term continuous infusion 5-fluorouracil (5-FU) in die treatment of advanced squamous carcinomas of various primary sites. METHODS. Patients were eligible for this trial if they had metastatic squam ous carcinoma at any site except the lung. In addition, patients with local ly 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 patien ts (20%) had received 1 previous chemotherapy regimen, whereas 48 patients (80%) were previously untreated. Ali patients received the following regime n: paclitaxel 200 mg/m(2), 1-hour intravenous infusion, Days 1 and 22; carb oplatin area under die concentration-time curve (AUC) 6.0 intravenously, Da ys 1 and 22; 5-FU 225 mg/m(2)/day, by 24-hour continuous intravenous infusi on, Days 1-35. Treatment courses were repeated at 6-week intervals; respond ing patients continued treatment for a maximum of 4 courses (24 weeks). RESULTS. Thirty-nine of 60 patients treated (65%) had objective responses t o this regimen, with 25% complete responses. Twelve patients (22%) remain p rogression free from 7 to 63 months (median, 35 months) after completion of therapy. Complete responses were observed in squamous carcinomas from vari ous 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 (2 8%), and portacath-related events (13%). CONCLUSIONS. The combination of paclitaxel, carboplatin, and long-term infu sional 5-FU is feasible, well tolerated, and highly efficacious in patients with advanced squamous carcinomas of various primary sites. This regimen m erits further investigation. Cancer 2001;92:642-9. (C) 2001 American Cancer Society.