A phase I trial of S-1 with oxaliplatin in patients with relapsed and metastatic colorectal cancer

International Journal of Colorectal Disease

Volumn 24, Issue 11, 2009, Pages 1311-1316

  Kim, Hyeong Su ^a   Park, Min Jae ^a   Uhm, Ji Eun ^a   Lee, Yuna ^a   Lee, Hui Young ^a   Kang, Eun Mi ^a   Lee, Jeeyun ^a   Park, Se Hoon ^a   Park, Joon Oh ^a   Lim, Ho Yeong ^a   Kang, Won Ki ^a   Park, Young Suk ^a  

^a Sungkyunkwan University School of Medicine   (South Korea)

Author keywords

Colorectal cancer; Oxaliplatin; Phase I study; S 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; OXALIPLATIN;

ADULT; AGED; ALOPECIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER MORTALITY; CANCER RADIOTHERAPY; CANCER RELAPSE; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; HEMATOLOGIC DISEASE; HUMAN; HYPERPIGMENTATION; INFECTION; MALE; MAXIMUM TOLERATED DOSE; METASTASIS; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; RECOMMENDED DRUG DOSE; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR VOLUME; VOMITING;

ADOLESCENT; ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; OXONIC ACID; RECURRENCE; TEGAFUR; TREATMENT OUTCOME; YOUNG ADULT;

EID: 70350003687     PISSN: 01791958     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00384-009-0758-3     Document Type: Article

References (19)

1. No authors listed (1992) Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project. J Clin Oncol 10:896-903
2. Shirao K, Ohtsu A, Takada H, Mitachi Y, Hirakawa K, Horikoshi N, Okamura T, Hirata K, Saitoh S, Isomoto H, Satoh A (2004) Phase II study of oral S-1 for treatment of metastatic colorectal carcinoma. Cancer 100:2355-2361
3. Ohtsu A, Baba H, Sakata Y, Mitachi Y, Horikoshi N, Sugimachi K, Taguchi T (2000) Phase II study of S-1, a novel oral fluorophyrimidine derivative, in patients with metastatic colorectal carcinoma. S-1 cooperative colorectal carcinoma study group. Br J Cancer 83:141-145
4. Shirasaka T, Nakano K, Takechi T, Satake H, Uchida J, Fujioka A, Saito H, Okabe H, Oyama K, Takeda S, Unemi N, Fukushima M (1996) Antitumor activity of 1M tegafur-0.4M 5-chloro-2, 4-dihydroxypyridine-1M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res 56:2602-2606
5. Yoshisue K, Hironaga K, Yamaguchi S, Yamamoto A, Nagayama S, Kawaguchi Y (2000) Reduction of 5-fluorouracil (5-FU) gastrointestinal (GI) toxicity resulting from the protection of thymidylate synthase (TS) in GI tissue by repeated simultaneous administration of potassium oxonate (Oxo) in rats. Cancer Chemother Pharmacol 46:51-56
6. Becouarn Y, Ychou M, Ducreux M, Borel C, Bertheault-Cvitkovic F, Seitz JF, Nasca S, Nguyen TD, Paillot B, Raoul JL, Duffour J, Fandi A, Dupont-Andre G, Rougier P (1998) Phase II trial of oxaliplatin as first-line chemotherapy in metastatic colorectal cancer patients. Digestive group of french federation of cancer centers. J Clin Oncol 16:2739-2744
7. Diaz-Rubio E, Sastre J, Zaniboni A, Labianca R, Cortes-Funes H, de Braud F, Boni C, Benavides M, Dallavalle G, Homerin M (1998) Oxaliplatin as single agent in previously untreated colorectal carcinoma patients: A phase II multicentric study. Ann Oncol 9:105-108
8. Maindrault-Goebel F, de Gramont A, Louvet C, Andre T, Carola E, Gilles V, Lotz JP, Tournigand C, Mabro M, Molitor JL, Artru P, Izrael V, Krulik M (2000) Evaluation of oxaliplatin dose intensity in bimonthly leucovorin and 48-hour 5-fluorouracil continuous infusion regimens (FOLFOX) in pretreated metastatic colorectal cancer. Oncology multidisciplinary research group (GERCOR). Ann Oncol 11:1477-1483
9. Sorbye H, Glimelius B, Berglund A, Fokstuen T, Tveit KM, Braendengen M, Ogreid D, Dahl O (2004) Multicenter phase II study of Nordic fluorouracil and folinic acid bolus schedule combined with oxaliplatin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 22:31-38
10. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, Chollet P, Llory JF, Letourneau Y, Coudert B, Bertheaut-Cvitkovic F, Larregain-Fournier D, Le Rol A, Walter S, Adam R, Misset JL, Levi F (2000) Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 18:136-147
11. Nukatsuka M, Saito H, Sakamoto K, Chikamoto J, Ooyama A, Uchida J, Sugimoto Y, Oka T, Fukushima M (2006) A new combination chemotherapy based on oral fluoropyrimidine, TS-1 combined with oxaliplatin is highly effective against colorectal cancer in vivo. AACR Meeting Abstracts 2006:1111-c
12. Cassidy J, Tabernero J, Twelves C, Brunet R, Butts C, Conroy T, Debraud F, Figer A, Grossmann J, Sawada N, Schoffski P, Sobrero A, Van Cutsem E, Diaz-Rubio E (2004) XELOX (capecitabine plus oxaliplatin): Active first-line therapy for patients with metastatic colorectal cancer. J Clin Oncol 22:2084-2091
13. Diaz-Rubio E, Tabernero J, Gomez-Espana A, Massuti B, Sastre J, Chaves M, Abad A, Carrato A, Queralt B, Reina JJ, Maurel J, Gonzalez-Flores E, Aparicio J, Rivera F, Losa F, Aranda E (2007) Phase III study of capecitabine plus oxaliplatin compared with continuous-infusion fluorouracil plus oxaliplatin as first-line therapy in metastatic colorectal cancer: Final report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial. J Clin Oncol 25:4224-4230
14. Van den Brande J, Schoffski P, Schellens JH, Roth AD, Duffaud F, Weigang-Kohler K, Reinke F, Wanders J, de Boer RF, Vermorken JB, Fumoleau P (2003) EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer. Br J Cancer 88:648-653
15. van Groeningen CJ, Peters GJ, Schornagel JH, Gall H, Noordhuis P, de Vries MJ, Turner SL, Swart MS, Pinedo HM, Hanauske AR, Giaccone G (2000) Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol 18:2772-2779
16. Kimura Y, Kikkawa N, Iijima S, Kato T, Naoi Y, Hayashi T, Tanigawa T, Yamamoto H, Kurokawa E (2003) A new regimen for S-1 therapy aiming at adverse reaction mitigation and prolonged medication by introducing a 1-week drug-free interval after each 2-week dosing session: Efficacy and feasibility in clinical practice. Gastric Cancer 6(Suppl 1):34-39
17. Ajani JA, Faust J, Ikeda K, Yao JC, Anbe H, Carr KL, Houghton M, Urrea P (2005) Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma. J Clin Oncol 23:6957-6965
18. Yamada Y, Tahara M, Miya T, Satoh T, Shirao K, Shimada Y, Ohtsu A, Sasaki Y, Tanigawara Y (2008) Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer. Br J Cancer 98:1034-1038
19. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A (2000) Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18:2938-2947