TY - JOUR
T1 - Phase I/II study of combination chemotherapy with gemcitabine and UFT for advanced pancreatic cancer in a multi-center trial
AU - Sumii, Toshihiko
AU - Funakoshi, Akihiro
AU - Mizumoto, Kazuhiro
AU - Tanaka, Masao
AU - Arita, Yoshiyuki
AU - Ito, Tetsuhide
AU - Yamaguchi, Hiroya
AU - Ueki, Toshiharu
AU - Sakai, Terufumi
AU - Miyahara, Toshihiko
AU - Muranaka, Toru
AU - Igarashi, Hisato
AU - Shinozaki, Hirotsugu
AU - Eriguchi, Naofumi
PY - 2008/4
Y1 - 2008/4
N2 - The aim of this phase I/II study was to evaluate the tolerability and efficacy of combination chemotherapy with gemcitabine (GEM) and UFT for advanced pancreatic cancer. In phase I study UFT was given orally every day for 14 days and GEM was infused on day 1 and 8 at three dose levels (800, 900, 1,000 mg/m(2)/week) every 21 days. GEM 1,000 mg/m(2) and UFT 400 mg/m(2) did not reach the maximum tolerated dose. We decided that the recommended dose (RD) was GEM 1,000 mg/m(2)and UFT 400 mg/m(2). In phase II study 27 patients were enrolled and received GEM and UFT at RD. The tumor response rate was 17.6%, and the median survival was 221 days, which was very similar to that of GEM monotherapy. Due to adverse events, especially liver dysfunction, protocol therapy was discontinued in 12 patients. This study could not revealed the superiority of the GEM monotherapy.
AB - The aim of this phase I/II study was to evaluate the tolerability and efficacy of combination chemotherapy with gemcitabine (GEM) and UFT for advanced pancreatic cancer. In phase I study UFT was given orally every day for 14 days and GEM was infused on day 1 and 8 at three dose levels (800, 900, 1,000 mg/m(2)/week) every 21 days. GEM 1,000 mg/m(2) and UFT 400 mg/m(2) did not reach the maximum tolerated dose. We decided that the recommended dose (RD) was GEM 1,000 mg/m(2)and UFT 400 mg/m(2). In phase II study 27 patients were enrolled and received GEM and UFT at RD. The tumor response rate was 17.6%, and the median survival was 221 days, which was very similar to that of GEM monotherapy. Due to adverse events, especially liver dysfunction, protocol therapy was discontinued in 12 patients. This study could not revealed the superiority of the GEM monotherapy.
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M3 - Article
C2 - 18408428
AN - SCOPUS:43549118899
SN - 0385-0684
VL - 35
SP - 603
EP - 606
JO - Gan to kagaku ryoho. Cancer & chemotherapy
JF - Gan to kagaku ryoho. Cancer & chemotherapy
IS - 4
ER -
