Combination Phase I Trial of a Novel Oral Fluorouracil Derivative S-1 with Low-Dose Cisplatin for Unresectable and Recurrent Gastric Cancer (JFMC27-9902)

Clinical Cancer Research

Volumn 10, Issue 5, 2004, Pages 1664-1669

  Nakata, Bunzo ^a   Mitachi, Yasushi ^b   Tsuji, Akihito ^c   Yamamitsu, Susumu ^d   Hirata, Koichi ^e   Shirasaka, Tetsuhiko ^f   Hirakawa, Kosei ^a  

^a OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b Sendai Kosei Hospital   (Japan)

^c National Hospital Organization   (Japan)

^d Sapporo Tsukisamu Hospital   (Japan)

^e SAPPORO MEDICAL UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f TAIHO PHARMACEUTICAL CO LTD   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; CISPLATIN; FLUOROURACIL DERIVATIVE;

ADULT; AGE DISTRIBUTION; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; BLOOD SAMPLING; BODY SURFACE; CANCER COMBINATION CHEMOTHERAPY; CANCER RECURRENCE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FATALITY; ECZEMA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; LEUKOPENIA; LIVER TOXICITY; LOW DRUG DOSE; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SKIN PIGMENTATION; STOMACH CARCINOMA; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FLUOROURACIL; HUMANS; LEUKOPENIA; LIVER NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PATIENT SELECTION; RECURRENCE; STOMACH NEOPLASMS;

EID: 1842533241     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-03-0045     Document Type: Article

References (19)

1. Cascinu, S., Labianca, R., Alessandroni, P., Marcellini, M., Silva, R., Pancera, G., Testa, E., Martignoni, G., Barni, S., Frontini, L., Zaniboni, A., Luporini, G., Cellerino, R., and Catalano, G. Intensive weekly chemotherapy for advanced gastric cancer using fluorouracil, cisplatin, epi-doxorubicin, 6S-leucovorin, glutathione, and filgrastim: a report from the Italian Group for the Study of Digestive Tract Cancer. J. Clin. Oncol., 15: 3313-3319, 1997.
2. Vanhoefer, U. Final results of a randomized Phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer of the Gastrointestinal Tract. J. Clin. Oncol., 18: 2648-2657, 2000.
3. Nakajima, T. Gastric cancer treatment guidelines in Japan. Gastric Cancer, 5: 1-5, 2002.
4. Shirasaka, T., Shimamoto, Y., Ohshimo, H., Yamaguchi, M., Kato, T., Yonekura, K., and Fukushima, M. Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anti-Cancer Drugs, 7: 548-557, 1996.
5. Shirasaka, T., Shimamoto, Y., and Fukushima, M. Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res., 53: 4004-4009, 1993.
6. Sugimachi, K., Maehara, Y., Horikoshi, N., Shimada, Y., Sakata, Y., Mitachi, Y., and Taguchi, T. An early Phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology, 57: 202-210, 1999.
7. Koizumi, W., Kurihara, M., Nakano, S., and Hasegawa, K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology, 58: 191-197, 2000.
8. Sakata, Y., Ohtsu, A., Horikoshi, N., Sugimachi, K., Mitachi, Y., and Taguchi, T. Late Phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1M tegafur-0.4M gimestat-1M ostat potassium) in advanced gastric cancer patients. Eur. J. Cancer, 34: 1715-1720, 1998.
9. Scanlon, K. J., Newman, E. M., Lu, Y., and Priest, D. G. Biochemical basis for cisplatin and 5-fluorouracil synergism in human ovarian carcinoma cells. Pro. Natl. Acad. Sci. USA, 83: 8923-8925, 1986.
10. Shirasaka, T., Shimamoto, Y., Ohshimo, H., Saito, H., and Fukushima, M. Metabolic basis of the synergistic antitumor activities of 5-fluorouracil and cisplatin in rodent tumor models in vivo. Cancer Chemother. Pharmacol., 32: 167-172, 1993.
11. Hirata, K., Horikoshi, N., Aiba, K., Okazaki, M., Denno, R., Sasaki, K., Nakano, Y., Ishizuka, H., Yamada, Y., Uno, S., Taguchi, T., and Shirasaka, T. Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin. Cancer Res., 5: 2000-2005, 1999.
12. Pera, M. F., and Harder, H. C. Analysis for platinum in biological material by flameless atomic absorption spectrometry. Clin. Chem., 23: 1245-1249, 1977.
13. World Health Organization. WHO Handbook for Reporting Results of Cancer Treatment. Offset Publication No. 48. Geneva: World Health Organization, 1979.
14. Japanese Society for Gastric Cancer. Japanese Classification of Gastric Carcinoma, First English Edition, pp. 90-104. Tokyo: Kanehara, 1995.
15. Kondo, K., Murase, M., Kodera, Y., Akiyama, S., Ito, K., Yokoyama, Y., Takagi, H., and Shirasaka, T. Feasibility study on protracted infusional 5-fluorouracil and consecutive low-dose cisplatin for advanced gastric cancer. Oncology, 53: 64-67, 1996.
16. Chung, Y. S., Yamashita, Y., Inoue, T., Matsuoka, T., Nakata, B., Onoda, N., Maeda, K., Sawada, T., Kato, Y., Shirasaka, T., and Sowa, M. Continuous infusion of 5-Fluorouracil and low dose cisplatin infusion for the treatment of advanced and recurrent gastric adenocarcinoma. Cancer (Phila.), 80: 1-7, 1997.
17. Kim, R., Murakami, S., Ohi, Y., Inoue, H., Yoshida, K., and Toge, T. A Phase II trial of low dose administration of 5-fluorouracil and cisplatin in patients with advanced and recurrent gastric cancer. Int. J. Oncol., 15: 921-926, 1999.
18. Cohen, S. J., Leichman, C. G., Yeslow, G., Beard, M., Proefrock, A., Roedig, B., Damle, B., Letrent, S. P., DeCillis, A. P., and Meropol, N. J. Phase I and pharmacokinetic study of once daily oral administration of S-1 in patients with advanced cancer. Clin. Cancer Res., 8: 2116-2122, 2002.
19. Iwahashi, M., Nakamori, M., Tani, M., Yamaue, H., Sakaguchi, S., Nakamura, M., Ueda, K., Matsuura, I., Nishino, E., and Tanimura, H. Complete response of highly advanced gastric cancer with peritoneal dissemination after new combined chemotherapy of S-1 and low-dose cisplatin: report of a case. Oncology, 61: 16-22, 2001.