Phase I study of combination chemotherapy consisting of paclitaxel, cisplatin, and S-1 in patients with unresectable gastric cancer (KOGC-02)

Tsunehiro Takahashi, Yoshiro Saikawa, Kazumasa Fukuda, Shinsuke Funakoshi, Hirofumi Kawakubo, Hiroya Takeuchi, Hiromasa Takaishi, Yuukou Kitagawa

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Abstract

Background: Triplet combination chemotherapy has the potential to improve the prognosis of patients with unresectable gastric cancer. We conducted a phase I trial of triplet combination chemotherapy consisting of paclitaxel, cisplatin, and S-1 (PCS) for unresectable gastric cancer. Patients and Methods: Patients with metastatic or incurable disease were enrolled. S-1 was administered on days 1-14. Paclitaxel and cisplatin were infused on days 1 and 15. The starting doses of paclitaxel and cisplatin were 100 and 20 mg/m 2, respectively. Dose levels of paclitaxel and cisplatin were escalated as follows: 120 and 20 mg/m2, respectively (level 2); 120 and 30 mg/m2, respectively (level 3). End-points: Dose-limiting toxicities included grade 3 nausea, vomiting, and general fatigue, and grade 4 febrile neutropenia. The maximum tolerated dose and recommended dose were established at level 3 and level 2, respectively. Conclusion: Although further clinical trials are recommended to more thoroughly evaluate safety and efficacy, PCS appears to be an excellent candidate for a standard treatment strategy for unresectable gastric cancer.

Original languageEnglish
Pages (from-to)5401-5406
Number of pages6
JournalAnticancer Research
Volume32
Issue number12
Publication statusPublished - 2012 Dec

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Combination Drug Therapy
Stomach Neoplasms
Febrile Neutropenia
Maximum Tolerated Dose
Nausea
Vomiting
Fatigue
TP protocol
Clinical Trials
Safety
Therapeutics

Keywords

  • Cisplatin
  • Combination chemotherapy
  • Gastric cancer
  • Paclitaxel
  • S-1

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase I study of combination chemotherapy consisting of paclitaxel, cisplatin, and S-1 in patients with unresectable gastric cancer (KOGC-02). / Takahashi, Tsunehiro; Saikawa, Yoshiro; Fukuda, Kazumasa; Funakoshi, Shinsuke; Kawakubo, Hirofumi; Takeuchi, Hiroya; Takaishi, Hiromasa; Kitagawa, Yuukou.

In: Anticancer Research, Vol. 32, No. 12, 12.2012, p. 5401-5406.

Research output: Contribution to journalArticle

Takahashi, Tsunehiro ; Saikawa, Yoshiro ; Fukuda, Kazumasa ; Funakoshi, Shinsuke ; Kawakubo, Hirofumi ; Takeuchi, Hiroya ; Takaishi, Hiromasa ; Kitagawa, Yuukou. / Phase I study of combination chemotherapy consisting of paclitaxel, cisplatin, and S-1 in patients with unresectable gastric cancer (KOGC-02). In: Anticancer Research. 2012 ; Vol. 32, No. 12. pp. 5401-5406.
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