Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors

Journal of Clinical Oncology

Volumn 18, Issue 14, 2000, Pages 2772-2779

  van Groeningen, Cees J ^a   Peters, Godefridus J ^a   Schornagel, Jan H ^a   Gall, Helen ^a   Noordhuis, Paul ^a   de Vries, Martin J ^a   Turner, Sue L ^a   Swart, Martha S ^a   Pinedo, Herbert M ^a   Hanauske, Axel R ^a   Giaccone, Giuseppe ^a  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

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

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER CHEMOTHERAPY; CANCER STAGING; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DRUG BLOOD LEVEL; DRUG INDUCED DISEASE; DRUG TOLERABILITY; FEMALE; HUMAN; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; TUMOR VOLUME;

EID: 18244414936     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2000.18.14.2772     Document Type: Article

References (30)

1. Diasio RB, Harris BE: Clinical pharmacology of 5-fluorouracil. Clin Pharmacokinet 16:215-237, 1989
2. Pinedo HM, Peters GJ: Fluorouracil: Biochemistry and pharmacology. J Clin Oncol 6:1653-1664, 1988
3. Peters GJ, van Groeningen CJ: Clinical relevance of biochemical modulation of 5-fluorouracil. Ann Oncol 2:469-480, 1991
4. Sotos GA, Grogan L, Allegra CJ: Preclinical and clinical aspects of biomodulation of 5-fluorouracil. Cancer Treat Rev 20:11-49, 1994
5. The Advanced Colorectal Cancer Meta-Analysis Project: Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. J Clin Oncol 10:896-903, 1992
6. Lokich JJ, Ahlgren JD, Gullo JJ, et al: A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: A Mid-Atlantic Oncology Program study. J Clin Oncol 7:425-432, 1989
7. Kurihara M: Clinical experience with UFT in Japan. Adv Exp Med Biol 339:243-251, 1993
8. Shirasaka T, Shimamoto Y, Ohshimo H, et al: 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. Anticancer Drugs 7:548-557, 1996
9. Peters GJ, van Groeningen CJ, Laurensse E, et al: A comparison of 5-fluorouracil metabolism in human colorectal cancer and colon mucosa. Cancer 68:1903-1909, 1991
10. Taguchi T, Inuyama Y, Kanamaru R, et al: Phase I study of S-1. Jpn J Cancer Chemother 24:2252-2264, 1997
11. Sakata Y, Ohtsu A, Horikoshi N, et al: Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1M tegafur-0.4M gimestat-1M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 34:1715-1720, 1998
12. Peters GJ, Lankelma J, Kok RM, et al: Prolonged retention of high concentrations of 5-fluorouracil in human and murine tumors as compared with plasma. Cancer Chemother Pharmacol 31:269-276, 1993
13. Peters GJ, Noordhuis P, Komissarov A, et al: Quantification of 5-fluorouracil incorporation into RNA of human and murine tumors as measured with a sensitive gas chromatography-mass spectrometry assay. Anal Bioch 231:157-163, 1995
14. Matsushima E, Yoshida K, Kitamura R, et al: Determination of S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) and 5-fluorouracil in human plasma and urine using high-performance liquid chromatography and gas chromatography-negative ion chemical ionization mass spectometry. J Chromatogr B Biomed Sci Appl 691:95-104, 1997
15. Cohen JL, Irwin LW, Marshall OJ, et al: Clinical pharmacology of oral and intravenous 5-fluorouracil (NSC-19893). Cancer Chemother Rep 58:723-731, 1974
16. Au JL, Sadee W: The pharmacology of ftorafur (R, S-1-(tetrahydro-2-furanyl)-5-fluorouracil. Recent Results Cancer Res 76: 100-114, 1981
17. Budman DR, Meropol NJ, Reigner B, et al: Preliminary studies of a novel oral fluoropyrimidine carbamate: Capecitabine. J Clin Oncol 16:1795-1802, 1998
18. Baccanari DP, Davis DT, Knick VC, et al: 5-Ethynyluracil (776C85): A potent modulator of the pharmacokinetics and antitumor activity of 5-FU. Proc Natl Acad Sci U S A 90:11064-11068, 1993
19. Pinedo HM, van Groeningen CJ: Vinorelbine: A horse of a different color? J Clin Oncol 12:1745-1747, 1994 (editorial)
20. Rowinsky EK, Noe DA, Trump DL: Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. J Clin Oncol 12:1754-1763, 1994
21. Weiss RB, Christian MC: New cisplatin analogues in development: A review. Drugs 46:360-377, 1993
22. Liu G, Franssen E, Fitch MI, et al: Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 15:110-115, 1997
23. Peters GJ: Antimetabolites, in Peckham M, Pinedo HM, Veronesi U (eds): Oxford Textbook of Oncology. Oxford, United Kingdom, Oxford Medical Publications, 1995, pp 524-552
24. van Groeningen CJ, Pinedo HM, Heddes J, et al: Pharmacokinetics of 5-fluorouracil assessed with a sensitive mass spectrometric method in patients on a dose escalation schedule. Cancer Res 48:6956-6961, 1988
25. Poorter RL, Peters GJ, Bakker PJ, et al: Intermittent continuous infusion of 5-fluorouracil and low dose oral leucovorin in patients with gastrointestinal cancer: Relationship between plasma concentrations and clinical parameters. Eur J Cancer 31A:1465-1470, 1995
26. Harris BE, Song R, Song S, et al: Relationship between dihydropyrimidine dehydrogenase activity and plasma 5-fluorouracil levels with evidence for circadian variation of enzyme activity and plasma drug levels in cancer patients receiving 5-fluorouracil by protracted continuous infusion. Cancer Res 50:197-201, 1990
27. Spicer DV, Ardalan B, Daniels JR, et al: Reevaluation of the maximum tolerated dose of continuous venous infusion of 5-fluorouracil with pharmacokinetics. Cancer Res 48:459-461, 1988s
28. Hirata K, Horikoshi N, Aiba K, et al: Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 5:2000-2005, 1999
29. Evans WE, Relling MV: Pharmacogenomics: Translating functional genomics into rational therapeutics. Science 286:487-491, 1999
30. El Sayed YM, Sadée W: Metabolic activation of ftorafur (R,S-1-(tetrahydro-2-furanyl)-5-fluorouracil): The microsomal oxidative pathway. Biochem Pharmacol 31:3006-3008, 1982