AN EARLY PHASE-II STUDY OF A 3-HOUR INFUSION OF PACLITAXEL FOR ADVANCED GASTRIC-CANCER

The purpose of this study was to evaluate the feasibility and efficacy of 3-hour infusional paclitaxel for the treatment of advanced gastric cancer with measurable metastatic diseases. Eligibility criteria incl uded no more than one regimen of prior chemotherapy. Paclitaxel was ad ministered as an intravenous infusion over 3 hours at a dose of 210 mg /m(2) every 3 weeks. Premedication of dexamethazone, ranitidine, and d iphenhydramine were given to all patients. Sixteen patients were regis tered in the study. One patient did not receive paclitaxel because of gastrointestinal bleeding before the initiation of drug's administrati on. Thirteen of the 15 patients had a prior history of chemotherapy. A lthough 10 patients (67%) developed grade 4 neutropenia, no serious in fections occurred during the study. Nonhematologic toxicities were gen erally mild. Three (20%) patients who showed evidences of resistance t o the previous intensive regimen achieved a partial response. In concl usion, a 3-hour infusion of paclitaxel is a safe and promising treatme nt for advanced gastric cancer. Paclitaxel appears to be non-cross res istant to other agents that are commonly used for gastric cancer. A la rge-scale phase ii study is now underway.