Phase I and pharmacokinetic study of tegafur-uracil/leucovorin combined with 5-fluorouracil/leucovorin and lrinotecan in patients with advanced colorectal cancer

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 32, Issue 1, 2009, Pages 56-60

  Chayahara, Naoko ^a,g   Tamura, Takao ^a,b,c   Yamamori, Motohiro ^d   Kadowaki, Yuko ^d   Okuno, Tatsuya ^a,c   Miki, Ikuya ^a   Tsuda, Masahiro ^e   Nishisaki, Hogara ^e   Maeda, Tetsuo ^f   Inoue, Yoshifumi ^f   Okumura, Katsuhiko ^c   Azuma, Takeshi ^a   Kasuga, Masato ^b   Sakaeda, Toshiyuki ^g   Hirai, Midori ^c,d  

^a Department of Gastroenterology ^*  (Japan)

^b Division of Diabetes Metabolism and Endcrinology   (Japan)

^c KOBE UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^d KOBE UNIVERSITY   (Japan)

^e HYOGO CANCER CENTER   (Japan)

^f Kawasaki Hospital   (Japan)

^g KYOTO UNIVERSITY   (Japan)

Author keywords

5 fluorouracil; Colorectal cancer; FOLFIRI; Pharmacokinetics; Phase I; UFT

Indexed keywords

ANTINEOPLASTIC AGENT; FLUOROURACIL; IRINOTECAN; UFT PLUS LEUCOVORIN; UNCLASSIFIED DRUG; CAMPTOTHECIN; DRUG DERIVATIVE; FOLINIC ACID; TEGAFUR;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BOLUS INJECTION; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DYSGEUSIA; FATIGUE; FEMALE; HAND FOOT SKIN REACTION; HUMAN; LEUKOPENIA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SKIN MANIFESTATION; STOMATITIS; THERAPY DELAY; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING; ADENOCARCINOMA; BONE TUMOR; COLORECTAL TUMOR; LIVER TUMOR; LUNG TUMOR; LYMPH NODE METASTASIS; MAXIMUM TOLERATED DOSE; METABOLISM; METASTASIS; MIDDLE AGED; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; LIVER NEOPLASMS; LUNG NEOPLASMS; LYMPHATIC METASTASIS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; SURVIVAL RATE; TEGAFUR; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

EID: 85047681933     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e31817c6a68     Document Type: Article

References (21)

1. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000; 355:1041-1047.
2. Goldberg RM, Sargent DJ, Motion RF, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004;22:23-30.
3. Tournigand C, Andre T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004;22:229-237.
4. Hoff PM, Pazdur R, Benner SE, et al. UFT and leucovorin: a review of its clinical development and therapeutic potential in the oral treatment of cancer. Anticancer Drugs. 1998;9:479-490.
5. Hoff PM, Royce M, Medgyesy D, et al. Oral fluoropyrimidines. Semin Oncol. 1999;26:640-646.
6. Douillard JY, Hoff PM, Skillings JR, et al. Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2002;20:3605-3616.
7. Carmichael J, Popiela T, Radstone D, et al. Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2002;20:3617-3627.
8. De Grève J, Koehne C, Hartmann J, et al. Capecitabine plus irinotecan versus 5-FU/FA/irinotecan ± celecoxib in first line treatment of metastatic colorectal cancer (CRC). Long-term results of the prospective multicenter EORTC phase III study 40015. Proc Am Soc Clin Oncol. 2006;24: abstract 3577.
9. Fuchs CS, Marshall J, Mitchell E, et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol. 2007;25:4779-4786.
10. Sobrero AF, Aschele C, Guglielmi AP, et al. Synergism and lack of cross-resistance between short-term and continuous exposure to fluorouracil in human colon adenocarcinoma cells. J Natl Cancer Inst. 1993;85:1937-1944.
11. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205-216.
12. Miki I, Tamura T, Nakamura T, et al. Circadian variability of pharmacokinetics of 5-fluorouracil and CLOCK T3111C genetic polymorphism in patients with esophageal carcinoma. Ther Drug Monit. 2005;27:369-374.
13. Sobrero AF, Aschele C, Bertino JR. Fluorouracil in colorectal cancer-a tale of two drugs: implications for biochemical modulation. J Clin Oncol. 1997; 15:368-381.
14. Mackay HJ, Hill M, Twelves C, et al. A phase I/II study of oral uracil/tegafur (UFT), leucovorin and irinotecan in patients with advanced colorectal cancer. Ann Oncol. 2003;14:1264-1269.
15. Veronese ML, Stevenson JP, Sun W, et al. Phase I trial of UFT/leucovorin and irinotecan in patients with advanced cancer. Eur J Cancer. 2004;40:508-514.
16. Delord JP, Bennouna J, Artru P, et al. Phase II study of UFT with leucovorin and irinotecan (TEGAFIRI): first-line therapy for metastatic colorectal cancer. Br J Cancer. 2007;97:297-301.
17. Bajetta E, Di Bartolomeo M, Buzzoni R, et al. Uracil/ftorafur/leucovorin combined with irinotecan (TEGAFIRI) or oxaliplatin (TEGAFOX) as firstline treatment for metastatic colorectal cancer patients: results of randomised phase II study. Br J Cancer. 2007;96:439-444.
18. Hochster HS, Hart LL, Ramanathan RK, et al. Safety and efficacy of oxaliplatin/ fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer (mCRC): final analysis of the TREE-Study. Proc Am Soc Clin Oncol. 2006;24: abstract 3510.
19. Ho DH, Pazdur R, Covington W, et al. Comparison of 5-fluorouracil pharmacokinetics in patients receiving continuous 5-fluorouracil infusion and oral uracil plus Nl-(2′-tetrahydrofuryl)-5-fluorouracil. Clin Cancer Res. 1998;4: 2085-2088.
20. Shirao K, Hoff PM, Ohtsu A, et al. Comparison of the efficacy, toxicity, and pharmacokinetics of a uracil/tegafur (UFT) plus oral leucovorin (LV) regimen between Japanese and American patients with advanced colorectal cancer: joint United States and Japan study of UFT/LV. J Clin Oncol. 2004;22:3466-3474.
21. Meropol NJ, Sonnichsen DS, Birkhofer MJ, et al. Bioavailability and phase II study of oral UFT plus leucovorin in patients with relapsed or refractory colorectal cancer. Cancer Chemother Pharmacol. 1999;43:221-226.