A Randomized Multicenter Study of Optimal Circadian Time of Vinorelbine Combined with Chronomodulated 5‐Fluorouracil in Pretreated Metastatic Breast Cancer Patients: EORTC Trial 05971

References

• Baron B, Legrand C, Lévi F, Hoctin‐Boes G. Chronomodulation: Optimal time finding design. 22nd annual meeting of the Society for Clinical Trials. Controlled Clin. Trials 2001; 22: 59S–60S
   Google Scholar
• Barrett R J, Blessing J A, Homesley H D, Twiggs L, Webster K D. Circadian‐timed combination doxorubicin‐cisplatin chemotherapy for advanced endometrial carcinoma. A phase II study of the Gynecologic Oncology Group. Am. J. Clin. Oncol. 1993; 16494–16496
   Google Scholar
• Berruti A, Sperone P, Bottini A, Gorzegno G, Lorusso V, Brunelli A, Botta M, Tampellini M, Donadio M, Mancarella S, De Lena M, Alquati P, Dogliotti L. Phase II study of vinorelbine with protracted fluorouracil infusion as a second‐ or third‐line approach for advanced breast cancer patients previously treated with anthracyclines. J. Clin. Oncol. 2000; 18: 3370–3377
   PubMed Web of Science ®Google Scholar
• Carlson R W, Anderson B O, Bensinger W, Cox C E, Davidson N E, Edge S B, Farrar W B, Goldstein L J, Gradishar W J, Lichter A S, McCormick B, Nabell L M, Reed E C, Silver S M, Smith M L, Somlo G, Theriault R, Ward J H, Winer E P, Wolff A. NCCN practice guidelines for breast cancer. Oncology (Williston Park) 2000; 14: 33–49
   PubMedGoogle Scholar
• Delcambre C, Bourgois H, Veyret C, Levy C, Switsers O, Allouache D, Grellard J M, Leconte A, Delozier T. A phase I/II study of capecitabine (X) combined with oral vinorelbine (V) as first or second‐line chemotherapy in patients (Pts) with locally advanced or metastatic breast cancer (MBC). Breast Cancer Res. Treat. 2004; 88: S68, abstract 1080, SABCS 2004, San Antonio, USA
   Google Scholar
• Dieras V, Extra J M, Bellissant E, Espie M, Morvan F, Pierga J Y, Mignot L, Tresca P, Marty M. Efficacy and tolerance of vinorelbine and fluorouracile combination as first line chemotherapy of advanced breast cancer: Results of a phase II study using a sequential group method. J. Clin. Oncol. 1996; 14: 3097–3104
   PubMed Web of Science ®Google Scholar
• Fety R, Urien S, Milano G, Kerbrat P, Bonneterre J, Fargeot P, Fumoleau P. A phase I pharmacokinetic (PK) and pharmacodynamic (PD) analysis of UFT/leucovorin (LV) in combination with vinorelbine (V). Proc. Am. Soc. Clin. Oncol. 2001; 20: 90a, abstract 355, ASCO Annual Meeting 2001
   Google Scholar
• Filipski E, Amat S, Lemaigre G, Vincenti M, Breillout F, Lévi F. Relationship between circadian rhythm of vinorelbine toxicity and efficacy in P388‐bearing mice. J. Pharmacol. Exp. Ther. 1999; 289: 231–235
   PubMedGoogle Scholar
• Filipski E, King V M, Li X, Granda T G, Mormont M C, Claustrat B, Hastings M H, Levi F. Disruption of circadian coordination accelerates malignant growth in mice. Pathol. Biol. (Paris). 2003; 51: 216–219
   PubMed Web of Science ®Google Scholar
• Filipski E, Innominato P F, Wu M, Li X M, Iacobelli S, Xian L J, Levi F. Effects of light and food schedules on liver and tumor molecular clocks in mice. J. Natl. Cancer Inst. 2005; 97: 507–517
   PubMed Web of Science ®Google Scholar
• Focan C. Rythms of cancer chronotherapy. Biological clocks: Pharmaceutical and therapeutic implications, P. H. Redfern. Pharmaceutical Press, London and Chicago 2002; 235–282
   Google Scholar
• Fu L, Lee C C. The circadian clock: Pacemaker and tumour suppressor. Nat. Rev. Cancer 2003; 3: 350–361
   PubMed Web of Science ®Google Scholar
• Fumoleau P, Deporte R, Kerbrat P, Bonneterre J, Fargeot P. UFT/leucovorin plus vinorelbine combination for advanced breast cancer. Oncology (Williston Park) 2000; 14: 50–55
   PubMedGoogle Scholar
• Giacchetti S, Bjarnason G, Garufi C, Genet D, Iacobelli S, Tampellini M, Smaaland R, Focan C, Coudert B, Humblet Y, Canon J L, Adenis A, Re G L, Carvalho C, Schueller J, Anciaux N, Lentz M A, Baron B, Gorlia T, Levi F. Phase III trial comparing four‐day chronomodulated therapy versus two‐day conventional delivery of fluorouracil, leucovorin, and oxaliplatin as first‐line chemotherapy of metastatic colorectal cancer: The European Organisation for Research and Treatment of Cancer Chronotherapy Group. J. Clin. Oncol. 2006; 24: 3562–3569
   PubMed Web of Science ®Google Scholar
• Gorbacheva V Y, Kondratov R V, Zhang R, Cherukuri S, Gudkov A V, Takahashi J S, Antoch M P. From the cover: Circadian sensitivity to the chemotherapeutic agent cyclophosphamide depends on the functional status of the CLOCK/BMAL1 transactivation complex. PNAS. 2005; 102: 3407–3412
   PubMed Web of Science ®Google Scholar
• Granda T G, Liu X H, Smaaland R, Cermakian N, Filipski E, Sassone‐Corsi P, Levi F. Circadian regulation of cell cycle and apoptosis proteins in mouse bone marrow and tumor. FASEB J. 2005; 19: 304–306
   PubMed Web of Science ®Google Scholar
• Hastings M H, Reddy A B, Maywood E S. A clockwork web: Circadian timing in brain and periphery, in health and disease. Nat. Rev. Neurosci. 2003; 4: 649–661
   PubMed Web of Science ®Google Scholar
• Hrushesky W J. Circadian timing of cancer chemotherapy. Science 1985; 228: 73–75
   PubMed Web of Science ®Google Scholar
• Kataja V V, Colleoni M, Bergh J. ESMO minimum clinical recommendations for diagnosis, treatment and follow‐up of locally recurrent or metastatic breast cancer (MBC). Ann. Oncol. 2005; 16(Suppl.1)i10–i12
   Google Scholar
• Lévi F. Circadian chronotherapy for human cancers. Lancet Oncol. 2001; 2: 307–315
   PubMed Web of Science ®Google Scholar
• Lévi F, Benavides M, Chevelle C, Le Saunier F, Bailleul F, Misset J L, Regensberg C, Vannetzel J M, Reinberg A, Mathé G. Chemotherapy of advanced ovarian cancer with 4‐O‐tetrahydropyranyl doxorubicin and cisplatin: A randomized phase II trial with an evaluation of circadian timing and dose intensity. J. Clin. Oncol. 1990; 8: 705–714
   PubMed Web of Science ®Google Scholar
• Lévi F, Misset J L, Brienza S, Adam R, Metzger G, Itzakhi M, Caussanel J P, Kunstlinger F, Lecouturier S, Scorps‐Declere A. A chronopharmacologic phase II clinical trial with 5‐fluorouracile, folinic acid and oxaliplatin using an ambulatory multichannel programmable pump. Cancer 1992; 69: 893–900
   PubMed Web of Science ®Google Scholar
• Lévi F, Zidani R, Vannetzel J M, Perpoint B, Focan C, Faggiuolo R, Chollet P, Garufi C, Itzhaki M, Dogliotti L, Iacobelli S, Adam R, Kunstlinger F, Gastiaburu J, Bismuth H, Jasmin C, Misset J L. Chronomodulated versus fixed infusion rate delivery of ambulatory chemotherapy with oxaliplatin, fluorouracil and folinic acid (leucovorin) in patients with colorectal cancer metastases: A randomized multi‐institutional trial. J. Natl. Cancer Inst. 1994; 86: 1608–1617
   PubMed Web of Science ®Google Scholar
• Lévi F, Soussan A, Adam R. A phase I/II trial of five days continuous intraveinous infusion of 5‐fluorouracil delivered at circadian rhythm modulated rate in patients with colorectal cancer. J. Infus. Chemother. 1995; 5: 153–158
   PubMedGoogle Scholar
• Lévi F, Zidani R, Misset J L. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. Lancet 1997; 350: 681–686
   PubMed Web of Science ®Google Scholar
• Li X M, Vincenti M, Levi F. Pharmacological effects of vinorelbine on body temperature and locomotor activity circadian rhythms in mice. Chronobiol. Int. 2002; 19: 43–55
   PubMed Web of Science ®Google Scholar
• Lis C G, Grutsch J F, Wood P, You M, Rich I, Hrushesky W J. Circadian timing in cancer treatment: The biological foundation for an integrative approach. Integr. Cancer Ther. 2003; 2: 105–111
   PubMedGoogle Scholar
• Lokich J. Optimal schedule for 5‐fluorouracil chemotherapy: Intermittent bolus or continuous infusion. Am. J. Clin. Oncol. 1985; 8: 445–448
   PubMed Web of Science ®Google Scholar
• Mormont M C, Lévi F. Cancer chronotherapy: Principles, applications, and perspectives. Cancer 2003; 97: 155–169
   PubMed Web of Science ®Google Scholar
• Natoli C, Salini V, Irtelli L, Martino M T, Garufi C, Grassadonia A, Fiorentino B, Iacobelli S. A phase I study of five‐day continuous venous infusion of carboplatin at circadian rhythm‐modulated rate compared with constant rate. Anticancer Res. 1996; 16: 1275–1279
   PubMedGoogle Scholar
• Nole F, Catania C, Sanna G, Imadalou K, Munzone E, Adamoli L, Longerey B, Blanchot G, Goldhirsch A. Dose‐finding and pharmacokinetic study of an all‐oral combination regimen of oral vinorelbine and capecitabine for patients with metastatic breast cancer. Ann. Oncol. 2006; 17: 322–329
   PubMed Web of Science ®Google Scholar
• Sano M, Tokuda Y, Noguchi S, Aogi K, Saeki T, Tabei T, Hatake K, Fujii H. [A phase‐I clinical study of a combination therapy of vinorelbine and capecitabine in patients with advanced/recurrent breast cancer]. Gan To Kagaku Ryoho 2006; 33: 1091–1097
   PubMedGoogle Scholar
• Tampellini M, Filipski E, Lévi F. Circadian variation of vinorebine toxicity in mice. Chronobiol. Int. 1995; 12: 195–198
   Web of Science ®Google Scholar
• Touitou Y, Smolensky M H, Portaluppi F. Ethics, standards, and procedures of animal and human chronobiology research. Chronobiol. Int. 2006; 23: 1083–1096
   PubMed Web of Science ®Google Scholar
• You S, Wood P A, Xiong Y, Kobayashi M, Du‐Quiton J, Hrushesky W J. Daily coordination of cancer growth and circadian clock gene expression. Breast Cancer Res. Treat. 2005; 91: 47–60
   PubMed Web of Science ®Google Scholar