Premium
Phase I study of paclitaxel plus irinotecan combination therapy for patients with refractory and advanced gastric cancer
Author(s) -
KOBAYASHI T.,
SAKAGAMI T.,
KOIZUKA H.,
YAMAMOTO N.,
SASAKI T.,
MAEDA Y.,
OMURO Y.,
OKAMOTO R.,
MIKOSHIBA M.,
SASAKI E.,
MATSUMOTO T.,
MIWA H.
Publication year - 2006
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2006.00055.x
Subject(s) - irinotecan , medicine , neutropenia , regimen , paclitaxel , chemotherapy , febrile neutropenia , refractory (planetary science) , gastroenterology , cancer , chemotherapy regimen , surgery , colorectal cancer , physics , astrobiology
Summary Background No adequate second‐line chemotherapy regimen for advanced gastric cancer is available. Aims To determine the safety and optimal dose of paclitaxel/irinotecan as a second‐line chemotherapy for patients with advanced and recurrent gastric cancer. Patients and methods Sixteen patients with refractory and advanced measurable gastric cancer who were resistant to 5‐FU plus cis‐diamminedichloroplatinum (CDDP) therapy (FP) were enrolled. Paclitaxel/irinotecan was given intravenously on days 1, 8, and 15 in repeated 4‐week cycles. Paclitaxel/irinotecan doses were escalated in a stepwise fashion as follows: 50/40 mg/m 2 , 50/50 mg/m 2 , 50/60 mg/m 2 , 60/60 mg/m 2 , 60/70 mg/m 2 in levels I, II, III, IV and V, respectively. Results Because of one patient with Grade 3 febrile neutropenia at level I, three more patients were enrolled in level I. Doses were consequently escalated, and in level IV, Grade 3 febrile neutropenia occurred in one patient. Since an additional patient in level IV had grade 4 neutropenia, Level IV was judged as the maximum tolerated dose (MTD). The recommended dose and schedule for phase II study is paclitaxel 50 mg/m 2 and irinotecan 60 mg/m 2 on days 1, 8, and 15 every 4 weeks. Partial response was observed in 4 of 16 patients. Conclusion Paclitaxel/irinotecan combination regimen at the level III dosage was safe and well tolerated.