Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer

Tomohiro Ozaki, Kenji Tamura, Taroh Satoh, Takayasu Kurata, Toshio Shimizu, Masaki Miyazaki, Isamu Okamoto, Kazuhiko Nakagawa, Masahiro Fukuoka

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: The primary objective of this study was to determine the maximum tolerated dose (MTD), the toxicity profile and the recommended dose (RD) for phase II of a combination of S-1 and weekly administration of docetaxel. Patients and Methods: Patients with histologically diagnosed recurrent or unresectable locally advanced gastric cancer were enrolled. A fixed oral dose of 80 mg/m2 S-1 was given for 3 weeks. Docetaxel was infused intravenously on day 1, 8 and 15, repeated every 5 weeks. A pharmacokinetic study was also performed. Results: A total of 14 patients were enrolled. One dose-limiting toxicity (DLT) (grade 3 diarrhea with febrile neutropenia) occurred at level 2. DLTs occurred in 3/5 patients at level 3, (grade 3 stomatitis, with febrile neutropenia or continuous grade 4 neutropenia). The pharmacokinetic study suggested no drug interactions. Overall response and disease control rates were 20% and 80%, respectively. The response rate at the RD (level 2) was 50%. Overall survival was 9.4 months. Conclusion: RD was level 2 (80 mg/m2 of S-1 for 3 weeks and 20 mg/m2 of docetaxel on day 1, 8 and 15, every 5 weeks). Dose intensities of S-1 and docetaxel were 48 mg/m2/week and 12 mg/m2/week, respectively. This regimen showed promising activity for advanced gastric cancer.

Original languageEnglish
Pages (from-to)2657-2665
Number of pages9
JournalAnticancer Research
Volume27
Issue number4 C
Publication statusPublished - Jul 2007
Externally publishedYes

Fingerprint

docetaxel
Stomach Neoplasms
Febrile Neutropenia
Pharmacokinetics
Stomatitis
Maximum Tolerated Dose
Therapeutics
Neutropenia
Drug Interactions
Diarrhea
Survival

All Science Journal Classification (ASJC) codes

  • Cancer Research
  • Oncology

Cite this

Ozaki, T., Tamura, K., Satoh, T., Kurata, T., Shimizu, T., Miyazaki, M., ... Fukuoka, M. (2007). Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer. Anticancer Research, 27(4 C), 2657-2665.

Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer. / Ozaki, Tomohiro; Tamura, Kenji; Satoh, Taroh; Kurata, Takayasu; Shimizu, Toshio; Miyazaki, Masaki; Okamoto, Isamu; Nakagawa, Kazuhiko; Fukuoka, Masahiro.

In: Anticancer Research, Vol. 27, No. 4 C, 07.2007, p. 2657-2665.

Research output: Contribution to journalArticle

Ozaki, T, Tamura, K, Satoh, T, Kurata, T, Shimizu, T, Miyazaki, M, Okamoto, I, Nakagawa, K & Fukuoka, M 2007, 'Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer', Anticancer Research, vol. 27, no. 4 C, pp. 2657-2665.
Ozaki T, Tamura K, Satoh T, Kurata T, Shimizu T, Miyazaki M et al. Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer. Anticancer Research. 2007 Jul;27(4 C):2657-2665.
Ozaki, Tomohiro ; Tamura, Kenji ; Satoh, Taroh ; Kurata, Takayasu ; Shimizu, Toshio ; Miyazaki, Masaki ; Okamoto, Isamu ; Nakagawa, Kazuhiko ; Fukuoka, Masahiro. / Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer. In: Anticancer Research. 2007 ; Vol. 27, No. 4 C. pp. 2657-2665.
@article{a70297aaa66d419b92f843eefa2af73b,
title = "Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer",
abstract = "Background: The primary objective of this study was to determine the maximum tolerated dose (MTD), the toxicity profile and the recommended dose (RD) for phase II of a combination of S-1 and weekly administration of docetaxel. Patients and Methods: Patients with histologically diagnosed recurrent or unresectable locally advanced gastric cancer were enrolled. A fixed oral dose of 80 mg/m2 S-1 was given for 3 weeks. Docetaxel was infused intravenously on day 1, 8 and 15, repeated every 5 weeks. A pharmacokinetic study was also performed. Results: A total of 14 patients were enrolled. One dose-limiting toxicity (DLT) (grade 3 diarrhea with febrile neutropenia) occurred at level 2. DLTs occurred in 3/5 patients at level 3, (grade 3 stomatitis, with febrile neutropenia or continuous grade 4 neutropenia). The pharmacokinetic study suggested no drug interactions. Overall response and disease control rates were 20{\%} and 80{\%}, respectively. The response rate at the RD (level 2) was 50{\%}. Overall survival was 9.4 months. Conclusion: RD was level 2 (80 mg/m2 of S-1 for 3 weeks and 20 mg/m2 of docetaxel on day 1, 8 and 15, every 5 weeks). Dose intensities of S-1 and docetaxel were 48 mg/m2/week and 12 mg/m2/week, respectively. This regimen showed promising activity for advanced gastric cancer.",
author = "Tomohiro Ozaki and Kenji Tamura and Taroh Satoh and Takayasu Kurata and Toshio Shimizu and Masaki Miyazaki and Isamu Okamoto and Kazuhiko Nakagawa and Masahiro Fukuoka",
year = "2007",
month = "7",
language = "English",
volume = "27",
pages = "2657--2665",
journal = "Anticancer Research",
issn = "0250-7005",
publisher = "International Institute of Anticancer Research",
number = "4 C",

}

TY - JOUR

T1 - Phase I study of combination therapy with S-1 and weekly docetaxel for advanced gastric cancer

AU - Ozaki, Tomohiro

AU - Tamura, Kenji

AU - Satoh, Taroh

AU - Kurata, Takayasu

AU - Shimizu, Toshio

AU - Miyazaki, Masaki

AU - Okamoto, Isamu

AU - Nakagawa, Kazuhiko

AU - Fukuoka, Masahiro

PY - 2007/7

Y1 - 2007/7

N2 - Background: The primary objective of this study was to determine the maximum tolerated dose (MTD), the toxicity profile and the recommended dose (RD) for phase II of a combination of S-1 and weekly administration of docetaxel. Patients and Methods: Patients with histologically diagnosed recurrent or unresectable locally advanced gastric cancer were enrolled. A fixed oral dose of 80 mg/m2 S-1 was given for 3 weeks. Docetaxel was infused intravenously on day 1, 8 and 15, repeated every 5 weeks. A pharmacokinetic study was also performed. Results: A total of 14 patients were enrolled. One dose-limiting toxicity (DLT) (grade 3 diarrhea with febrile neutropenia) occurred at level 2. DLTs occurred in 3/5 patients at level 3, (grade 3 stomatitis, with febrile neutropenia or continuous grade 4 neutropenia). The pharmacokinetic study suggested no drug interactions. Overall response and disease control rates were 20% and 80%, respectively. The response rate at the RD (level 2) was 50%. Overall survival was 9.4 months. Conclusion: RD was level 2 (80 mg/m2 of S-1 for 3 weeks and 20 mg/m2 of docetaxel on day 1, 8 and 15, every 5 weeks). Dose intensities of S-1 and docetaxel were 48 mg/m2/week and 12 mg/m2/week, respectively. This regimen showed promising activity for advanced gastric cancer.

AB - Background: The primary objective of this study was to determine the maximum tolerated dose (MTD), the toxicity profile and the recommended dose (RD) for phase II of a combination of S-1 and weekly administration of docetaxel. Patients and Methods: Patients with histologically diagnosed recurrent or unresectable locally advanced gastric cancer were enrolled. A fixed oral dose of 80 mg/m2 S-1 was given for 3 weeks. Docetaxel was infused intravenously on day 1, 8 and 15, repeated every 5 weeks. A pharmacokinetic study was also performed. Results: A total of 14 patients were enrolled. One dose-limiting toxicity (DLT) (grade 3 diarrhea with febrile neutropenia) occurred at level 2. DLTs occurred in 3/5 patients at level 3, (grade 3 stomatitis, with febrile neutropenia or continuous grade 4 neutropenia). The pharmacokinetic study suggested no drug interactions. Overall response and disease control rates were 20% and 80%, respectively. The response rate at the RD (level 2) was 50%. Overall survival was 9.4 months. Conclusion: RD was level 2 (80 mg/m2 of S-1 for 3 weeks and 20 mg/m2 of docetaxel on day 1, 8 and 15, every 5 weeks). Dose intensities of S-1 and docetaxel were 48 mg/m2/week and 12 mg/m2/week, respectively. This regimen showed promising activity for advanced gastric cancer.

UR - http://www.scopus.com/inward/record.url?scp=34547729862&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34547729862&partnerID=8YFLogxK

M3 - Article

VL - 27

SP - 2657

EP - 2665

JO - Anticancer Research

JF - Anticancer Research

SN - 0250-7005

IS - 4 C

ER -