Phase II study of a triplet regimen in advanced colorectal cancer using methotrexate, oxaliplatin and 5-fluorouracil

British Journal of Cancer

Volumn 91, Issue 8, 2004, Pages 1428-1433

  Guglielmi, A ^a   Barni, S ^b   Zaniboni, A ^c   Pella, N ^d   Belvedere, O ^e   Beretta, G D ^f   Grossi, F ^e   Frontini, L ^g   Puglisi, F ^e   Labianca, R ^f   Sobrero, A ^a  

^a UNIVERSITY OF GENOA   (Italy)

^b TREVIGLIO HOSPITAL   (Italy)

^c Medical Oncology   (Italy)

^d SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

^e UNIVERSITY OF UDINE   (Italy)

^f OSPEDALI RIUNITI   (Italy)

^g Clinic San Pio X   (Italy)

Author keywords

5 fluorouracil; Chemotherapy; Colorectal cancer; Methotrexate; Oxaliplatin

Indexed keywords

FLUOROURACIL; FOLINIC ACID; METHOTREXATE; OXALIPLATIN; ANTINEOPLASTIC AGENT; PLATINUM COMPLEX;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BOLUS INJECTION; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONJUNCTIVITIS; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE TIME EFFECT RELATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG SAFETY; FEMALE; HAND FOOT SYNDROME; HUMAN; MALE; MUCOSA INFLAMMATION; NAUSEA; NEUROTOXICITY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SURVIVAL TIME; TREATMENT OUTCOME; VOMITING; COLORECTAL TUMOR; DISEASE FREE SURVIVAL; FEASIBILITY STUDY; LIVER TUMOR; LUNG TUMOR; METASTASIS; MIDDLE AGED; PATHOLOGY; PERITONEUM TUMOR;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; FEASIBILITY STUDIES; FEMALE; FLUOROURACIL; HUMANS; LIVER NEOPLASMS; LUNG NEOPLASMS; MALE; METHOTREXATE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; PERITONEAL NEOPLASMS; TREATMENT OUTCOME;

EID: 7944234918     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6602176     Document Type: Article

References (34)

1. André T, Figer A, Cervantes A, Lledo G, Flesch M, Maindrault-Goebel F, Mineur L, Russ G, Buyse M, De Gramont A (2003) FOLFOX7 compared to FOLFOX4. Preliminary results of the randomized optimox study. Proc Am Soc Clin Oncol 22: 1016
2. Aschele C, Guglielmi A, Frassineti GL, Milandri C, Amadori D, Labianca R, Vinci M, Tixi L, Caroti C, Ciferri E, Verdi E, Rosso R, Sobrero A (1998) Schedule selective biochemical modulation of 5-fluorouracil in advanced colorectal cancer: a multicentric phase II study. Br J Cancer 177: 341-346
3. Baldwin J (2002) FDA evaluating oxaliplatin for advanced colorectal cancer treatment. J Natl Cancer Inst 94: 1191-1193
4. Bennouna J, Perrier H, Paillot B, Priou F, Jacob IH, Hebbar M, Bordenave S, Seitz JF, Tonelli D, Douillard JY (2003) Tegafox, a new combination of UFT/LV and oxaliplatin as first line treatment for patients with non resectable metastatic colorectal cancer: results of a completed multicenter phase II trial. Proc Am Soc Clin Oncol 22: 1088
5. Borner M, Schsffski P, de Wit R, Caponigro F, Comella G, Sulkes A, Peters G, Grynwald V, Wanders J, de Boer R, Mrtin C, Fumoleau P (2000) A randomized crossover trial comparing oral UFT (Uracil/tegafur)+leucovorin (LV) and intravenous fluorouracil (FU)+LV for patient preference and pharmacokinetics in advanced colorectal cancer. Proc Am Soc Clin Oncol 19: 741
6. Cassidy J, Twelves C, Van Cutsem E, Hoff P, Bajetta E, Boyer M, Bugat R, Burger U, Garin A, Graeven U, McKendric J, Maroun J, Marshall J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schilsky RL, Capecitabine Colorectal Cancer Study Group (2002) First-line oral capecitabine therapy in metastatic colorectal cancer: a favourable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 13: 566-575
7. Cunningham D, de Gramont A, Scheitauer W, Smakal M, Humblet Y, Kurteva G, Iveson T, Andre T, Dostalova J, Illes A, Jia X, Palmer P (2002) Randomized double-blind placebo-controlled trial of farnesyltransferase inhibitor R115777 (Zamestra) in advanced refractory colorectal cancer. Proc Am Soc Clin Oncol 21: 502
8. Cunningham D, Glimelius B (1999) A phase III study of irinotecan (CPT-11) vs best supportive care in patients with metastatic colorectal cancer who have failed 5-fluorouracil therapy. V301 Study Group. Semin Oncol 26: 6-12
9. 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 of advanced colorectal cancer. J Clin Oncol 18: 2938-2947
10. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicenter randomised trial. Lancet 15: 1372-1379
11. Fischel JL, Etienne MC, Formento P, Milano G (1998) Search for optimal schedule for the oxaliplatin/5-fluorouracil association modulated or not by folinic acid: preclinical data. Clin Cancer Res 4: 2529-2535
12. Giantonio BJ, Levy D, Catalano P, O'Dwyer PJ, Benson AB (2002) Incorporating angiogenesis inhibition with bevacizumab (anti VEGF) into front-line chemotherapy with irinotecan (CPT-11), fluorouracil and leucovorin (FU/LV) for advanced colorectal cancer (advCRC): a toxicity analysis of ECOG study E2200. Proc Am Soc Clin Oncol 21: 503
13. Goldberg RM, Morton RF, Sargent DJ, Fuchs C, Ramanathan RK, Williamson SK, Findlay BP (2003) N9741: oxaliplatin (Oxal) or CPT-11+5-fluorouracil(5-FU)/ leucovorin (LV) or oxal+CPT-11 in advanced colorectal cancer (CRC). Updated efficacy and quality of life (QOL) data from an intergroup study. Proc Am Soc Clin Oncol 22: 1009
14. Grothey A, Deschler B, Kroening H, Ridwelski K, Reichardt P, Kretzschmar A, Clemens M, Hirschmann W, Lorenz M, Asperger W, Buechele T, Schmoll HJ (2002) Phase III study of bolus 5-fluorouracil (5-FU)/folinic acid (FA) (Mayo) vs weekly high-dose 24h 5-FU infusional/FA+oxaliplatin (OXA) (FUFOX) in advanced colorectal cancer (ACRC). Proc Am Soc Clin Oncol 21: 512
15. Grothey A, Jordan K, Kellner O, Costantin C, Dittrich G, Kroening H, Mantovani L, Schlichting C, Forstbauer H, Schmoll HJ (2003) Randomized phase II trial of capecitabine plus irinotecan (CapIRI) vs capecitabine plus oxaliplatin (CapOX) as first-line therapy for advanced colorectal cancer (ACRC). Proc Am Soc Clin Oncol 22: 1022
16. Hochster H, Chachoua A, Speyer J, Escalon J, Zeleniuc-Jacquotte A, Muggia F (2003) Oxaliplatin with weekly bolus fluorouracil and low-dose leucovorin as first-line therapy for patients with colorectal cancer. J Clin Oncol 21: 2703-2707
17. Jonker DJ, Maroun JA, Kocha W (2000) Survival benefit of chemotherapy in metastatic colorectal cancer: a meta-analysis of randomised trial. Br J Cancer 82: 1789-1794
18. Kaplan E, Meier P (1958) Non-parametric estimation from incomplete observations. J Am Stat Assoc 53: 457-458
19. King J, Clingan P, Morris DL (2002) Placebo-control double-blind randomised clinical trial of the matrix metalloproteinase inhibitor (MMP) marimastat in patients with inoperable colorectal cancer liver metastases (CRCLM): significant survival advantage in patients with musculoskeletal symptoms. Proc Am Soc Clin Oncol 21: 537
20. Knight RD, Miller LL, Pirotta N, Elfring GL, Locker PK, Saltz LB (2000) First-line irinotecan (C), fluorouracil (F), leucovorin (L) especially improve survival (OS) in metastatic colorectal cancer (MCRC) patients (PT) with favourable prognostic indicators. Proc Am Soc Clin Oncol 19: 991
21. Leichman CG, Leichman L, Spears CP, Rosen PJ, Jeffers S, Groshen S (1993) Prolonged infusion of fluorouracil with weekly bolus leucovorin: a phase II study in patients with disseminated colorectal cancer. J Natl Cancer Inst 85: 41-44
22. Levi F, Zigani L, Coudert B, Antoine E, Cajfinger F, Rocher M, Coeffic D, Spano J, Taillibert S, Bismuth H, Khayat D (2001) Chronomodulated irinotecan (I)-Fluorouracil (F)-Leucovorin (L)-Oxaliplatin (O) (CHRONO IFLO) as salvage therapy in patients with heavily pretreated metastatic colorectal cancer. Proc Am Soc Clin Oncol 20: 558
23. Liu G, Franssen E, Fitch M, Warner E (1997) Patient preferences for oral vs intravenous palliative chemotherapy. J Clin Oncol 15: 110-115
24. Marsh JC, Bertino JR, Katz KH, Davis CA, Durivage HJ, Rome LS, Richards II F, Capizzi RL, Farber LR, Pasquale DN (1991) The influence of drug interval on the effect of methotrexate and fluorouracil in the treatment of advanced colorectal cancer. J Clin Oncol 9: 371-380
25. Miller AB, Hoogstraten B, Staquet M, Winkler A (1981) Reporting results of cancer treatment. Cancer 47: 207-214
26. Ravaioli A, Marangolo M, Pasquini E, Rossi A, Amadori D, Cruciani G, Tassinari D, Oliverio G, Giovanis P, Turci D, Zumaglini F, Nicolini M, Panzini I (2002) Bolus fluorouracil and leucovorin with oxaliplatin as first-line treatment in metastatic colorectal cancer. J Clin Oncol 20: 2545-2550
27. Saltz L, Rubin M, Hochster H, Tchekmeydian NS, Waksal H, Needle M, LoBuglio A (2001) Cetuximab (IMC-C225) plus irinotecan (CPT-11) is active in CPT-11 refractory colorectal cancer that expresses epidermal growth factor receptor (EGFR). Proc Am Soc Clin Oncol 20: 7
28. Saltz LB, Cox JV, Blande C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL (2000) Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 28: 905-914
29. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10: 1-10
30. Sobrero A, Aschele C, Guglielmi A, Mori AM, Melioli GG, Rosso R, Bertino JR (1993) Synergism and lack of cross-resistance between short-term and continuous exposure to fluorouracil in human colon adenocarcinoma cells. J Natl Cancer Inst 85: 1937-1944
31. Sobrero A, Guglielmi A, Cirillo M, Recaldin E, Frassineti GL, Aschele C, Ravaioli A, Testore P, Caroti C, Gallo L, Pessi MA, Cortesi E, Turci D, Grossi F, Labianca R (2001) 5-Fluorouracil modulated by leucovorin, methotrexate and mytomicin: highly effective, low-cost chemotherapy for advanced colorectal cancer. Br J Cancer 84: 1023-1028
32. Sobrero A, Zaniboni A, Frassineti GL, Aschele C, Guglielmi A, Giuliani R, Ravaioli A, Lanfranco C, Caroti C, Arnoldi E, Barni S, Gallo L, Pessi MA, Turci D, Cortesi E, Grossi F, Frontini L, Piazza E, Bruzzi P, Labianca R (2000) Schedule specific biochemical modulation of 5-fluorouracil in advanced colorectal cancer: a randomized study. GISCAD, IOR and collaborating centers. Ann Oncol 11: 1-8
33. Sobrero AF, Aschele C, Guglielmi A, Mori AM, Tixi LM, Bolli EA, Rosso R, Mammoliti S, Rollandi GA, Bertoglio S (1995) Schedule-selective biochemical modulation of 5-fluorouracil: a phase II study in advanced colorectal cancer. Clin Cancer Res 1: 955-960
34. Van Cutsem E, Twelves C, Tabernero J, Schoffski P, Figer A, Diaz-Rubio E, De Braud F, Conroy T, Cassidy J, Butts C, on behalf of XELOX phII investigators (2003) XELOX: mature results of a multinational, phase II trial of capecitabine plus oxaliplatin, an effective 1st line option for patients with metastatic colorectal cancer (MCRC). Proc Am Soc Clin Oncol 22: 1023