PACLITAXEL AND CONCURRENT RADIATION FOR LOCALLY ADVANCED PANCREATIC AND GASTRIC-CANCER - G PHASE-I STUDY

Purpose: To determine the maximum-tolerated dose (MTD), dose-limiting toxicities, and potential antitumor activity of weekly paclitaxel with concurrent radiation (RT) for locally advanced pancreatic and gastric cancer. Patients and Methods: Thirty-four patients with locally advan ced adenocarcinoma of the pancreas or stomach were studied. The initia l dose of paclitaxel was 30 mg/m(2) by 3-hour intravenous (IV) infusio n repeated every week for 6 weeks with 50 Gy RT. Doses were escalated at 10-mg/m(2) increments in successive cohorts of three new patients u ntil dose-limiting toxicity was observed. Results: The dose-limiting t oxicities at 60 mg/m(2)/wk were abdominal pain within the RT field, na usea, and anorexia. Of 23 patients with assessable disease, 11 (seven with gastric, four with pancreatic cancer) had objective responses for an overall response rate of 48%. Conclusion: Concurrent paclitaxel wi th upper abdominal RT is well tolerated at dosages that have substanti al activity. A phase II trial of neoadjuvant paclitaxel and RT at the MTD of 50 mg/m(2)/wk is underway. (C) 1997 by American Society of Clin ical Oncology.