A phase I study of combination therapy of the oral fluorinated pyrimidine compound S-1 with low-dose cisplatin twice-a-week administration (JFMC27-9902 Step2) in patients with advanced gastric cancer using a continual reassessment method

Japanese Journal of Clinical Oncology

Volumn 37, Issue 12, 2007, Pages 924-929

  Morita, Satoshi ^a   Nakata, Bunzo ^b   Tsuji, Akihito ^c   Mitachi, Yasushi ^d   Shirasaka, Tetsuhiko ^e   Saji, Shigetoyo ^f   Ohashi, Yasuo ^g   Sakamoto, Junichi ^a   Hirakawa, Kosei ^b  

^a NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

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

^c Kochi Health Sciences Center   (Japan)

^d Tohoku Employees' Pension Welfare Hospital   (Japan)

^e KITASATO UNIVERSITY   (Japan)

^f Japanese Foundation for Multidisciplinary Treatment of Cancer   (Japan)

^g UNIVERSITY OF TOKYO   (Japan)

Author keywords

Continual reassessment method; Gastric cancer; Low dose cisplatin; Phase I clinical study; S 1

Indexed keywords

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

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ASSESSMENT TOOL; CLINICAL DECISION MAKING; CLINICAL TRIAL; DIARRHEA; DOSE CALCULATION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; LEUKOPENIA; LOW DRUG DOSE; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PATIENT MONITORING; PHASE 1 CLINICAL TRIAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SKIN MANIFESTATION; STOMACH CANCER; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; ALGORITHMS; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA; CISPLATIN; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; LYMPHATIC METASTASIS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; OXONIC ACID; PATIENT SELECTION; RESEARCH DESIGN; STOMACH NEOPLASMS; TEGAFUR; TREATMENT OUTCOME;

EID: 38749103940     PISSN: 03682811     EISSN: 14653621     Source Type: Journal    
DOI: 10.1093/jjco/hym124     Document Type: Article

References (21)

1. Sugimachi K, Maehara Y, Horikoshi N, Shimada Y, Sakata Y, Mitachi Y, et al. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-10.
2. Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000;58:191-7.
3. Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y, Taguchi T. Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur-0.4 M gimestat-1 M ostat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-20.
4. Hyodo I, Nishina T, Moriwaki T, Endo S, Terao T, Hirao K, et al. A phase I study of S-1 combined with weekly cisplatin for metastatic gastric cancer in an outpatient setting. Eur J Cancer 2003;39: 2328-33.
5. Nakata B, Mitachi Y, Tsuji A, Yamamitsu S, Hirata K, Shirasaka T, et al. Combination therapy of a novel oral fluorouracil derivative S-1 with low-dose cisplatin for unresectable and recurrent gastric cancer: A multicenter phase I study. Clin. Cancer Res. 2004;10: 1664-9.
6. Shimoyama S, Imamura K, Hiki N, Yamaguchi H, Mafune K, Kaminishi M. Performance of outpatient regimen of S-1 in combination with fractional cisplatin for advanced or recurrent gasw cancers: A phase I study. Int J Clin Oncol 2005;10:251-5.
7. Koizumi W, Tanabe S, Saigenji K, Ohtsu A, Boku N, Nagashima F, et al. Phase I/II study of S-1 combined with cisplatin in patients with advanced gastric cancer. Br J Cancer 2003;89:2207-12.
8. Ajani JA, Faust J, Ikeda K, Yao JC, Anbe H, Carr KL, et al. Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma. J Clin Oncol 2005;23:6957-65.
9. Yoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y, et al. Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin Cancer Res 2006;12:3402-7.
10. Yamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H, et al. Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer 2006;94:1803-8.
11. Ueda Y, Yamagishi H, Ichikawa D, Morii J, Koizumi K, Kakihara N, et al. Phase I study of a combination of S-1 and weekly paclitaxel in patients with advanced or recurrent gastric cancer. Oncology 2005;69:261-8.
12. Inokuchi M, Yamashita T, Yamada H, Kojima K, Ichikawa W, Nihei Z, et al. Phase I/II study of S-1 combined with irinotecan for metastatic advanced gastric cancer. Br J Cancer 2006;94:1130-5.
13. Morita S, Ohashi Y, Hirakawa K, Nakata B, Saji S, Sakamoto J. Phase I/II study of combination therapy of oral fluorinated pyrimidine compound S-1 with low-dose cisplatin in patients with unresectable and/or recurrent advanced gastric cancer: A novel study design to evaluate safety and efficacy. Jpn J Clin Oncol 2004;34:159-61.
14. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: A practical design for Phase I clinical trials in cancer. Biometrics 1990;46:33-48.
15. O'Quigley J, Shen LZ. Continual reassessment method: A likelihood approach. Biometrics 1996;52:673-84.
16. O'Quigley J. Phase I and phase I/II dose finding algorithms using continual reassessment method. In: Crowley J editor. Handbook of Statistics in Clinical Oncology, 2nd edn. New York: CRC Press 2005.
17. Yagihashi A, Sasaki K, Hirata K, Yamamitsu S. Study of serum CDDP concentrations in patients with advanced or recurrent adeno- or squamous cell carcinoma under combination chemotherapy of 5-FU (CIV) and low-dose CDDP (IV). Gan to Kagaku Ryoho (Jpn J Cancer Chemother) 1996;23:63-7.
18. Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med 1995;14:1149-61.
19. Ohashi Y. Recent proposals for early stage clinical trials of cancer. Jpn J Cancer Chemother 1994;21:292-4 (in Japanese).
20. Thall PF, Lee SJ. Practical model-based dose-finding in phase I clinical trials: Methods based on toxicity. Int J Gynecol Cancer 2003;13: 251-61.
21. Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics 2004;60:684-93.