A phase I study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma

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To establish the maximum tolerated dose and dose-limiting toxicity of chemoradiation with paclitaxel (PTX) and cisplatin (CDDP) for patients with local symptoms due to unresectable primary advanced or locally recurrent gastric adenocarcinoma located at left-upper abdomen. Chemotherapy consisted of PTX at escalating doses of 40-80 mg/m(2) per day and CDDP at escalating doses of 20-25 mg/m(2) per day on days 1, 15, and 29. Concurrent radiation was administered up to a dose of 45 Gy for 5 weeks. A total of nine patients were enrolled, of which six were into level 1 (PTX 60 mg/m(2) and CDDP 20 mg/m(2)) and three into level -1 (PTX 50 mg/m(2) and CDDP 20 mg/m(2)). At level 1, one patient developed grade 3 fatigue, and the other experienced grade 5 DIC, grade 5 pneumonia, grade 4 thrombocytopenia, grade 3 hyponatremia, and grade 3 esophagitis as dose-limiting toxicities. A palliative effect was observed in eight of nine patients; six of six patients at level 1 and two of three at level -1. PTX 50 mg/m(2) and CDDP 20 mg/m(2) given biweekly with concurrent radiation therapy of 45 Gy were well tolerated.