Paclitaxel and concurrent radiation for locally advanced pancreatic and gastric cancer: a phase I study.
OBJECTIVE
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.


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%.


CONCLUSIONS
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.
Safran
H
H
Brown University, Providence, RI, USA. howard_safran@brown.edu
King
T P
TP
Choy
H
H
Hesketh
P J
PJ
Wolf
B
B
Altenhein
E
E
Sikov
W
W
Rosmarin
A
A
Akerley
W
W
Radie-Keane
K
K
Cicchetti
G
G
Lopez
F
F
Bland
K
K
Wanebo
H J
HJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000627:therapeutic use*; D010190:Pancreatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D014057:Tomography, X-Ray Computed
D000972:Antineoplastic Agents, Phytogenic; D011838:Radiation-Sensitizing Agents; D017239:Paclitaxel