A multi-center, phase ii clinical trial of Padexol (paclitaxel) and cisplatin for patients suffering with advanced gastric cancer.
OBJECTIVE
We conducted a multi-center, phase II trial to evaluate the efficacy and safety of using Padexol (a paclitaxel formulation) combined with cisplatin for the patients suffering with advanced gastric adenocarcinoma.


METHODS
39 patients (median age: 60 years; males: 90%) who were diagnosed with advanced gastric cancer were enrolled from 5 hospitals. Padexol 175 mg/m² was administered as a 3-hr infusion, and this was followed by cisplatin 75 mg/m² as an intravenous infusion on day 1, once every 3 weeks.


RESULTS
Out of these 39 patients, 34 patients were assessable for treatment efficacy and 39 patients were assessable for the toxicity. Objective responses occurred in 13 patients (33%); 1 patient (3%) had a complete response and 12 patients (31%) had partial responses. 6 patients (15%) achieved a stable disease state. The median duration of response was 7.1 months, and the median time to progression and the overall survival were 4.8 months and 6.7 months, respectively. The major treatment-related adverse events were hematologic toxicity, including WHO grade 3 or 4 neutropenia in 13 patients (33%). However, febrile neutropenia occurred in only 1 patient and the non-hematologic toxicity was usually mild.


CONCLUSIONS
The combination of Padexol and cisplatin was found to be active and it seems to be a relatively well-tolerated regimen for the treatment of advanced gastric cancer.
Kim
Min Kyoung
MK
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Lee
Kyung Hee
KH
Hyun
Myung Soo
MS
Do
Young Rok
YR
Song
Hong Suk
HS
Lee
Won Sik
WS
Park
Keon Uk
KU
Baek
Jin Ho
JH
Kim
Jong Gwang
JG