Journal of Clinical Oncology, Vol 15, 901-907, Copyright © 1997 by American Society of Clinical Oncology
Paclitaxel and concurrent radiation for locally advanced pancreatic and gastric cancer: a phase I study
H Safran, TP King, H Choy, PJ Hesketh, B Wolf, E Altenhein, W Sikov, A Rosmarin, W Akerley, K Radie-Keane, G Cicchetti, F Lopez, K Bland and HJ Wanebo
Brown University, Providence, RI, USA. howard_safran@brown.edu
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 advanced
adenocarcinoma of the pancreas or stomach were studied. The initial dose of
paclitaxel was 30 mg/m2 by 3-hour intravenous (I.V.) infusion repeated
every week for 6 weeks with 50 Gy RT. Doses were escalated at 10-mg/m2
increments in successive cohorts of three new patients until dose-limiting
toxicity was observed. RESULTS: The dose- limiting toxicities at 60
mg/m2/wk were abdominal pain within the RT field, nausea, 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 with upper abdominal RT is well
tolerated at dosages that have substantial activity. A phase II trial of
neoadjuvant paclitaxel and RT at the MTD of 50 mg/m2/wk is underway.
