A phase II Japanese study of a modified capecitabine regimen for advanced or metastatic colorectal cancer

Anti-Cancer Drugs

Volumn 15, Issue 2, 2004, Pages 137-143

  Sakamoto, Junichi ^a   Kondo, Yukifumi ^b   Takemiya, Shoji ^c   Sakamoto, Nobuaki ^d   Nishisho, Isamu ^e  

^a KYOTO UNIVERSITY   (Japan)

^b Sapporo Kousei Hospital   (Japan)

^c KANAGAWA CANCER CENTER   (Japan)

^d TOKYO MEDICAL UNIVERSITY   (Japan)

^e OSAKA NATIONAL HOSPITAL   (Japan)

Author keywords

Capecitabine (Xeloda ); Colorectal cancer; Japanese intermittent regimen; Phase II study

Indexed keywords

CAPECITABINE;

ADULT; AGED; ANOREXIA; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FEVER; HAND FOOT SYNDROME; HEMATOLOGIC DISEASE; HUMAN; HYPERBILIRUBINEMIA; INSOMNIA; JAPAN; LABORATORY TEST; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 1542329003     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001813-200402000-00006     Document Type: Article

References (28)

1. 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 1992; 10:896-903.
2. De Gramont A, Bosset JF, Milan C, Rougier P, Bouche O, Etienne PL, et al. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 1997; 15:808-815.
3. Leichman CG, Fleming TR, Muggia FM, Tangen CM, Ardalan B, Doroshow JH, et al. Phase II study of fluorouracil and its modulation in advanced colorectal cancer: a Southwest Oncology Group study. J Clin Oncol 1995; 13:1303-1311.
4. Payne SA. A study of quality of life in cancer patients receiving palliative chemotherapy. Soc Sci Med 1992; 35:1505-1509.
5. Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997; 15:110-115.
6. Borner MM, Schoffski P, de Wit R, Caponigro F, Comella G, Sulkes A, et al. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 2002; 38:349-358.
7. Douillard J-Y, Hoff PM, Skillings JR, Eisenberg P, Davidson N, Harper P, 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.
8. Schilsky RL, Levin J, West WH, Wong A, Colwell B, Thirlwell MP, et al. Randomized, open-label, phase III study of a 28-day oral regimen of eniluracil plus fluorouracil versus intravenous fluorouracil plus leucovorin as first-line therapy in patients with metastatic/advanced colorectal cancer. J Clin Oncol 2002; 20:1519-1526.
9. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, et al. Design of a novel oral fluoropyrimidine carbamate capecitabine which generates 5-fluorouracil selectively in tumors by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998; 34:1274-1281.
10. Ishikawa T, Utoh M, Sawada N, Nishida M, Fukase Y, Sekiguchi F, Ishitsuka H. Tumor selective delivery of 5-fluorouracil by capecitabine, a new oral fluoropyrimidine carbamate, in human cancer xenografts. Biochem Pharmacol 1998; 55:1091-1097.
11. Pazdur R, Douillard JY, Skillings JR, Eisenberg PD, Davidson N, Harper P, et al. Multicenter phase III study of 5-fluorouracil (5-FU) or UFT™ in combination with leucovorin (LV) in patients with metastatic colorectal cancer. Proc Am Soc Clin Oncol 1999; 18:263 (abstr A1009).
12. Taguchi T, Ishitani K, Saitoh K, Kurihara M, Tominaga T, Fukuyama Y, et al. A Japanese Phase 1 study of continuous twice daily treatment with capecitabine in patients with advanced and/or metastatic solid tumors. NCI-EORTC Symp on New Dugs in Cancer Therapy 1996; 9:299 (abstr).
13. Kondo Y, Terashima M, Sato A, Taguchi T. on behalf of the Clinical Study Group of Capecitabine. A pilot phase II study of capecitabine in advanced or recurrent colorectal cancer. In press.
14. Japanese Society for Cancer of the Colon and Rectum. General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus, 5th edn. Japanese Society for Cancer of the Colon and Rectum 1994.
15. National Cancer Institute of Canada. Common Toxicity Criteria (NCIC-CTC) Grading System. National Cancer Institute of Canada 1991.
16. Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1999; 17:485-493.
17. Blum JL, Dieras V, Lo Russo PM, Norton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, phase II study of oral capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer 2001; 92:1759-1768.
18. Fumoleau P, Largillier R, Trillet-Lenoir V, Orfeuvre H, Extra J-M, Lesimple T, et al. Phase II study of capecitabine (Xeloda®) in pts with advanced breast cancer (ABC), previously treated with anthracyclines and taxanes. Breast Cancer Res Treat 2001; 69:285 (abstr 435).
19. Talbot DC, Moiseyenko V, Van Belle S, O'Reilly SM, Alba Conejo E, Ackland S, et al. Randomised, phase II trial comparing oral capecitabine (Xeloda) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines. Br J Cancer 2002; 86:1367-1372.
20. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20:2812-2823.
21. Twelves C. Capecitabine as first-line treatment in colorectal cancer: pooled daa from two large, phase III trials. Eur J Cancer 2002; 38(suppl 2):15-20.
22. Cassidy J, Twelves C, Van Cutsem E, Hoff P, Bajetta E, Boyer M, et al. Capecitabine Colorectal Cancer Study Group. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 2002; 13:566-575.
23. Kerr DJ, Ten Bokkel Huinink WW, Ferry DR, Rea DW, Boussard BM, Oulid-Aissa D, et al. A phase I/II study of CPT-11 in combination with capecitabine as first line chemotherapy for metastatic colorectal cancer (MCRC). Proc Am Soc Clin Oncol 2002; 21:abstr 643.
24. Tewes M, Schleucher N, Achterrath W, Wilke HJ, Frings S, Seeber S, et al. Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study. Ann Oncol 2003; 14:1442-1448.
25. Diaz-Rubio E, Evans TR, Tabemero J, Cassidy J, Sastre J, Eatock M, et al. Capecitabine (Xeloda) in combination with oxaliplatin: a phase I, dose-escalation study in patients with advanced or metastatic solid tumors. Ann Oncol 2002; 13:558-565.
26. Van Cutsem E, Twelves C, Tabernero J, Schoffski P, Figer A, Diaz-Rubio E, et al. XELOX: mature results of a multinational, phase II trial of capecitabine plus oxaliplatin, an effective 1st line option for patients (pts) with metastatic colorectal cancer (MCRC). Proc Am Soc Clin Oncol 2003; 22:255 (abstr 1023).
27. Dunst J, Reese T, Sutter T, Zuhlke H, Hinke A, Kolling-Schlebusch K, et al. Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer. J Clin Oncol 2002; 20:3983-3991.
28. Kennedy AS, Van Echo DA, Volpe C, Moesinger R, Shibata D, Darwin P, et al. Phase I studies using capecitabine combined with conformal radiation therapy (RT), paclitaxel, CPT-11 and celecoxib in gastrointestinal malignancies. Proc Am Soc Clin Oncol 2002; 21:abstr 3021.