European Journal of Cancer
Volume 42, Issue 5 , Pages 608-616 , March 2006

Randomised phase II study of standard versus chronomodulated CPT-11 plus chronomodulated 5-fluorouracil and folinic acid in advanced colorectal cancer patients

  • Carlo Garufi

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy
    • Corresponding Author InformationCorresponding author. Tel.: +39 6 52666222; fax: +39 6 52666219.
    • ,
  • Barbara Vanni

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy
    • ,
  • Anna Maria Aschelter

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy
    • ,
  • Albina Rita Zappalà

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy
    • ,
  • Emilio Bria

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy
    • ,
  • Cecila Nisticò

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy
    • ,
  • Isabella Sperduti

      Affiliations

    • Biostatistic Unit, Istituto Regina Elena, Rome, Italy
    • ,
  • Francesco Cognetti

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy
    • ,
  • Edmondo Terzoli

      Affiliations

    • Department of Medical Oncology, Istituto Regina Elena, Via Chianesi, 53, 00144 Rome, Italy

Received 25 February 2005 ,Accepted 1 March 2005.

References 

  1. Van Cutsem E, Cunningham D, Ten Bokkel Huinink WW, et al. Clinical activity and benefit of irinotecan (CPT-11) in patients with colorectal cancer truly resistant to 5-fluorouracil. Eur J Cancer. 1999;35:54–59
  2. Mathijssen RH, van Alphen RJ, Verweij J, et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res. 2001;7:2182–2194
  3. Douillard JY, Cunningham D, Roth A, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer. A multicentre randomised trial. Lancet. 2000;355:1041–1057
  4. Kohne CH, Van Cutsem E, Wils JA, et al. Irinotecan improves the activity of the AIO regimen in metastatic colorectal cancer: results of EORTC GI Group study 40986. Proc Am Soc Clin Onocol. 2003;22:1018a
  5. Lévi F. Circadian chronotherapy for human cancer. Lancet Oncol. 2001;2:307–315
  6. Mormont MC, Lévi F. Cancer chronotherapy: principles, applications and perspectives. Cancer. 2003;97:155–169
  7. Bjarnason GA, Jordan RC, Wood PA, et al. Circadian expression of clock genes in human oral mucosa and skin. Am J Pathol. 2001;15:1793–1801
  8. Badiu C. Genetic clock of biologic rhythms. J Cell Mol Med. 2003;7:408–416
  9. Matsuo T, Yamaguchi S, Mitsui S, et al. Control mechanism of the circadian clock for timing of cell division in vivo. Science. 2003;10:255–259
  10. Saccone C, Maggese C, D’Erchia AM, et al. Molecular clock and gene function. J Mol Evol. 2003;57(Suppl. 1):S277–S285
  11. Garufi C, Lévi F, Aschelter AM, et al. A phase I trial of 5-day chronomodulated infusion of fluorouracil and l-folinic acid in patients with metastatic colorectal cancer. Eur J Cancer. 1997;33:1566–1571
  12. Cure H, Chevalier V, Adenis A, et al. Phase II trial of chronomodulated infusion of high-dose fluorouracil and l-folinic acid in previously untreated patients with metastatic colorectal cancer. J Clin Oncol. 2002;20:1175–1181
  13. Lévi F, Perpoint B, Garufi C, et al. Oxaliplatin activity against metastatic colorectal cancer. A phase II study of 5-day continuous infusion at circadian rhythm modulated rate. Eur J Cancer. 1993;29A:1280–1284
  14. Lévi F, Misset JL, Brienza S, et al. A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid and oxaliplatin using an ambulatory multichannel programmable pump. High antitumor effectiviness against metastatic colorectal cancer. Cancer. 1992;69:
  15. Bertheault-Cvitkovic F, Jami A, Ithzaki M, et al. Biweekly intensified ambulatory chronomodulated chemotherapy with oxaliplatin, 5-fluorouracil and folinic acid in patients with metastatic colorectal cancer. J Clin Oncol. 1996;14:2950–2958
  16. Filipski E, Lévi F, Vadrot N, et al. Circadian changes in irinotecan toxicity in mice. Proc AACR. 1997;38:2048
  17. Ohdo S, Makinosumi T, Ishizaki T, et al. Cell cycle-dependent chronotoxicity of irinotecan hydrochloride in mice. J Pharmacol Exp Ther. 1997;283:1383–1388
  18. Giacchetti S., et al. In: Proc ECCO 2001, Lisbona.
  19. Garufi C, Dogliotti L, D’Attino RM, et al. Irinotecan and chronomodulated infusionof 5-fluorouracil and folinic acid in the tratment of patients with advanced colorectal carcinoma. A phase I study. Cancer. 2001;91:712–720
  20. Garufi C, Zappalà AR, Aschelter AM, et al. Comparison between bolus and chronomodulated CPT11 to chrono 5FU and folinic acid in advanced colorectal cancer patients. Proc Am Soc Clin Oncol. 2002;21:[abs. 692]
  21. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer. 1981;47:207–215
  22. MacDonald J, Haller D, Mayer R. Grading of toxicity. In:  MacDonald J,  Haller D,  Mayer R editor. Manual of oncologic therapeutics. Philadelphia, PA: Lippincott; 1995;p. 519–523
  23. Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001;20:859–866
  24. Kaplan EL, Meier P. Nonparametric estimation from incomplete observation. J Am Stat Assoc. 1958;53:475–481
  25. Ohe Y, Sasaki Y, Shinkai T, et al. Phase I study and pharmacokinetics of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst. 1992;84:972–974
  26. Takimoto CH, Morrison G, Harold N, et al. Phase I and pharmacologic study of irinotecan administered as a 96-hour infusion weekly to adult cancer patients. J Clin Oncol. 2000;18:659–667
  27. Masi G, Falcone A, Di Paolo A, et al. A phase I and pharmacokinetic study of irinotecan given as a 7-day continuous infusion in metastatic colorectal cancer patients pretreated with 5-fluorouracil or raltitrexed. Clin Cancer Res. 2004;10:1657–1663
  28. Giacchetti S, Bjarnason GA, Garufi C, et al. Firstnline infusion of 5-fluorouracil, leucovorin and oxaliplatin for metastatic colorectal cancer: 4-day chronomodulated (FFL4-10) versus 2-day FOLFOX2. A multicenter randomized Phase III trial of the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer (EORTC 05963). Proc ASCO 2004, abs 3526.
  29. Scheitauer W, Kornek GB, Raderer M, et al. Randomized multicenter phase II trial of two different schedules of capecitabine plus oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2003;21:1307–1312
  30. Buyse M, Thiron P, Carlson RW, et al. Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-Analysis Group in Cancer. Lancet. 2000;356:373–378
  31. Sephton SE, Sapolsky RM, Kramer HC, et al. Diurnal cortisol rhythm as a predictor of breast cancer survival. J Natl Cancer Inst. 2000;92:994–1000
  32. Mormont MC, Waterhouse J, Bleuzen P, et al. Marked 24-h rest/activity rhythms are associated with better quality of life, better response, and longer survival in patients with metastatic colorectal cancer and good performance status. Clin Cancer Res. 2000;6:3038–3045
  33. Ohdo S, Koyanagi S, Suyama H, et al. Changing the dosing schedule minimizes the disruptive effects of interferon on clock function. Nat Med. 2001;7:356–360
  34. Koyanagi S, Ohdo S. Alteration of intrinsic biological rhythms during interferon treatment and its possible mechanism. Mol Pharmacol. 2002;62:1393–1399

PII: S0959-8049(05)00220-0

doi: 10.1016/j.ejca.2005.03.012

European Journal of Cancer
Volume 42, Issue 5 , Pages 608-616 , March 2006

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