Pharmacokinetic linearity of i.v. vinorelbine from an intra-patient dose escalation study design

Cancer Chemotherapy and Pharmacology

Volumn 54, Issue 3, 2004, Pages 193-205

  Khayat, David ^a   Rixe, Olivier ^a   Brunet, René ^b   Goupil, Alain ^c   Bugat, Roland ^d   Harousseau, Jean Luc ^e   Ifrah, Norbert ^f   Puozzo, Christian ^g  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^b INSTITUT BERGONIÉ   (France)

^c Rene Huguenin Hospital   (France)

^d INSTITUT CLAUDIUS REGAUD   (France)

^e NANTES UNIVERSITY HOSPITAL   (France)

^f ANGERS UNIVERSITY HOSPITAL   (France)

^g INSTITUT DE RECHERCHE PIERRE FABRE   (France)

Author keywords

Blood plasma; Linearity; Pharmacokinetics; Phase I study; PK PD; Vinorelbine

Indexed keywords

ANTINEOPLASTIC AGENT; NAVELBINE;

ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BIOCHEMISTRY; BLEEDING; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE CALCULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG URINE LEVEL; FEMALE; HEART DISEASE; HEMATOLOGY; HUMAN; INTESTINE OBSTRUCTION; KIDNEY CLEARANCE; KIDNEY DISEASE; LEUKOPENIA; LIFE EXPECTANCY; LIVER DISEASE; LUNG DISEASE; MALE; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; SKIN DISEASE; STOMATITIS; TUMOR; VOMITING;

EID: 4344694630     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-004-0794-1     Document Type: Article

References (73)

1. Jacquillat CI, Khayat D, Weill UU, Band PR (1986) Les cancers - guide clinique, pronostique et thérapeutique. Edi Maloine
2. Chabner BA, Horwitz SB, Clendennin NJ, Purvis JP (1991) Vinca alkaloids. Cancer Chemother Biol Response Modif 12:67-73
3. Duflos A, Kruczynski A, Barret JM (2002) Novel aspects of natural and modified vinca alkaloids. Curr Med Chem Anti-Canc Agents 2(1):55-70
4. Corvalan JR, Smith W, Gore VA (1988) Tumour therapy with vinca alkaloids targeted by a hybrid-hybrid monoclonal antibody recognising both CEA and vinca alkaloids. Int J Cancer 2:22-25
5. Kruczynski A, Etievant C, Perrin D et al (2002) Characterization of cell death induced by vinflunine, the most recent vinca alkaloid in clinical development. Br J Cancer 86(1):143-150
6. Kruczynski A, Barret JM, Etievant C et al (1998) Antimitotic and tubulin-interacting properties of vinflunine, a novel fluorinated vinca alkaloid. Biochem Pharmacol 55(5):635-648
7. Fedeli L, Colozza M, Boschetti E et al (1989) Pharmacokinetics of Vincristine in cancer patients treated with Nifedipine. Cancer 64(9):1805-1811
8. Focan C, Doalto L, Mazy V et al (1989) Vindesine en perfusion continue (suivie de Cisplatine) dans le cancer pulmonaire avancé Données chrono-pharmacocinétiques et efficacité clinique. Bull Cancer 76(8):909-912
9. Jackson DV, Sethi VS, Spurr CL et al (1981) Pharmacokinetics of Vincristine infusion. Cancer Treat Rep 65:1043-1046
10. Ohnuma T, Norter L, Andejazul A, Holland JF (1985) Pharmacokinetics of Vindesine given as an intravenous bolus and 24-hour infusion in humans. Cancer Res 45:464-469
11. Owellen RJ, Root MA, Hains FO (1977) Pharmacokinetics of Vindesine and Vincristine in Humans. Cancer Res 37:2603-2607
12. Pinkerton CR, Mcdermott B, Philip T et al (1988) Continuous Vincristine infusion as part of a high dose chemotherapy regimen drug kinetics and toxicity. Cancer Chemother Pharmacol 22:271-274
13. Rahmani R, Samak R, Bore P, Cano JP (1988) Pharmacocinétique clinique des vinca-alcaloides. Bull Cancer 75:195-200
14. Rahmani R, Gueritte F, Martin M et al (1986) Comparative Pharmacokinetics of antitumor vinca alkaloids: intravenous bolus injections of Navelbine and related alkaloids to cancer patient and rats. Chemother Pharmacol 16:223-228
15. Bore P, Rahmani R, Van Confort J et al (1989) Pharmacokinetics of the new antitumor drug Navelbine in patients. Cancer Chemother Pharmacol 23:247-251
16. Rahmani R, Martin M, Barbet J, Cano JP (1984) Radioimmunoassay and preliminary pharmacokinetics studies in rats of 5′-Noranhydrovinblastine Navelbine. Cancer Res 44:5609-5613
17. Rahmani R, Bruno R, Iliadis A et al (1987) Clinical pharmacokinetics of the antitumor drug Navelbine (5′-Noranhydrovinblastine). Cancer Res 47:5796-5799
18. Krikorian A, Rahmani R, Bromet M et al (1989) Pharmacokinetics and metabolism of Navelbine. Semin Oncol 16(4):21-25
19. Solere P, Lucas C (1991) Limites analytiques en pharmacocinétique clinique: l'exemple des vinca-alcaloïdes. Bull Cancer 78:775-787
20. Mangeney P, Andriamialisoa RZ, Lallemand JY et al (1979) A new class of antitumor compounds: 5′-nor and 5′,6′-seco derivatives of vinblastine-type alkaloids. J Org Chem 44:3765-3768
21. Mangeney P, Andriamialisoa RZ, Lallemand JY et al (1979) 5′-noranhydrovinblastine prototype of a new class of vinblastine derivatives. Tetrahedron 35:2175-2179
22. Marty M, Extra JM, Espie M et al (1989) Advances in vinca-alkaloids: navelbine. Nouv Rev Fr Hematol 31:77-84
23. Hill BT (2001) Vinflunine, a second generation novel vinca alkaloid with a distinctive pharmacological profile, now in clinical development and prospects for future mitotic blockers. Curr Pharm Des 7(13):1199-1212
24. Fellous A, Ohayon R, Vacassin T et al (1989) Biochemical effects of navelbine on tubulin and associated proteins. Semin Oncol 16(4):9-14
25. Marquet P, Lachatre G, Debord J et al (1992) Pharmacokinetics of vinorelbine in man. Eur J Clin Pharmacol 42:545-547
26. Schilling T, Fiebig HH, Kerpel-Fronius S et al (1996) Clinical phase I and pharmacokinetic trial of vinorelbine administered as single intravenous bolus every 21 days in cancer patients. Invest New Drug 14:371-376
27. Wargin WA, Lucas VS (1994) The clinical pharmacokinetics of vinorelbine (Navelbine). Semin Oncol 21(5)Suppl 10:21-27
28. Leveque D, Jehl F, Quoix E, Monteil H (1993) Pharmacokinetic profile of vinorelbine, a new semi-synthetic vinca alkaloid, determined by high-performance liquid chromatography. Xenobiotica 23(11):1325-1333
29. Mathe G, Reizenstein P (1985) Phase I pharmacologic study of a new vinca alkaloid: navelbine. Cancer Lett 27:285-293
30. Krikorian A, Breillout F (1991) Vinorelbine (Navelbine), a new semisynthetic vinca alkaloid. Onkologie 14:7-12
31. Toso C, Lindley C (1995) Vinorelbine: a novel vinca alkaloid. Am J Health Syst Pharm 52:1287-1303
32. Crawford J, O'Rourke M, Schiller JH et al (1996) Randomized trial of vinorelbine compared with fluorouracil plus leucovorin in patients with stage IV non-small cell lung cancer. J Clin Oncol 14:2774-2784
33. Depierre A, Chastang C, Quoix E et al (1994) Vinorelbine versus vinorelbine plus cisplatin in advanced non-small cell lung cancer: a randomized trial. Ann Oncol 5:37-42
34. Furuse K, Kubota K, Kawahara M et al (1994) Japan vinorelbine lung cancer study group: a phase II study of vinorelbine, a new derivative of vinca alkaloid, for previously untreated advanced non-small cell lung cancer. Lung Cancer 11:385-391
35. Masotti A, Zannini G, Poggi R, Morandini GC (1994) Vinorelbine monochemotherapy in non-small-cell lung cancer: experience in patients with low performance status. Monaldi Arch Chest Dis 49:197-200
36. Depierre A, Lemarie E, Dabouis G et al (1991) A phase II study of navelbine (vinorelbine) in the treatment of non-small cell lung cancer. Am J Clin Oncol 14:115-119
37. Fossella FV, Devore R, Kerr RN et al (2000) Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens - the TAX 320 non-small cell lung cancer group. J Clin Oncol 18:2354-2362
38. Pronzato P, Landucci M, Vaira F et al (1994) Failure of vinorelbine to produce responses in pretreated non-small cell lung cancer patients. Anticancer Res 14:1413-1415
39. Rinaldi M, Della Giulia M, Venturo I et al (1994) Vinorelbine as single agent in the treatment of advanced non-small cell lung cancer. Proceedings of ASCO 1994; Abstract 1212, Dallas, USA
40. Santoro A, Maiorino L, Santoro M (1994) Second-line vinorelbine in the weekly monochemotherapy for the treatment of advanced non-small cell lung cancer. Lung Cancer 11(1):310
41. Vogel C, O'Rourke M, Winer E et al (1999) Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Ann Oncol 10:397-402
42. Fumoleau P, Delgado FM, Delozier T et al (1993) Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 11:1245-1252
43. Garcia-Conde J, Lluch A, Martin M et al (1994) Phase II trial of weekly iv vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 5:854-857
44. Bruno S, Puerto VL, Mickiewicz E et al (1995) Phase II trial of weekly iv vinorelbine as a single agent in first-line advanced breast cancer chemotherapy. The Latin-American experience. Am J Clin Oncol 18:392-396
45. Romero A, Rabinovich MG, Vallejo CT et al (1994) Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 12:336-341
46. Degardin M, Bonneterre J, Hecquet B et al (1994) Vinorelbine (navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 5:423-426
47. Gasparini G, Caffo O, Barni S et al (1994) Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: a phase II study. J Clin Oncol 12:2094-2101
48. Fumoleau P, Delecroix V, Perrocheau G et al (1996) Final results of a phase I dose finding and pharmacokinetic (PK) study of docetaxel in combination with vinorelbine in metastatic breast cancer. Ann Oncol 7(5):126
49. Romero Acuna L, Langhi M, Perez J et al (1999) Vinorelbine and paclitaxel as first-line chemotherapy in metastatic breast cancer. J Clin Oncol 17(1):74-81
50. Goedhals L, Vorobiof DA, Bezwoda W et al (1999) Phase II trial of iv vinorelbine and cisplatin in inoperable locally advanced or disseminated non-small-cell lung cancer: the South African experience. Curr Med Res Opin 15(3):185-192
51. Isokangas OP, Knuuttila A, Halme M et al (1999) Phase II study of vinorelbine and gemcitabine for inoperable stage IIIB-IV non-small-cell lung cancer. Ann Oncol 10:1059-1063
52. Frasci G, Lorusso V, Panza N et al (2001) Gemcitabine plus vinorelbine yields better survival outcome than vinorelbine alone in elderly patients with advanced non-small cell lung cancer. A Southern Italy Cooperative Oncology Group (SICOG) phase III trial. Lung Cancer 34:S65-S69
53. Fujushita T, Loda M, Turner RE et al (2003) Sensitivity of non-small cell lung cancer cell lines established from patients treated with prolonged infusions of paclitaxel. Oncology 64(4):399-406
54. Rosen FR, Haraf DJ, Kies MS et al (2003) Multicenter randomised phase II study of paclitaxel (1-hour infusion), fluorouracil, hydroxyurea, and concomitant twice daily radiation without erythropoietin for advanced head and neck cancer. Clin Cancer Res 9(5):1689-1697
55. Henningsson A, Sparreboom A, Sandstrom M et al (2003) Population pharmacokinetic modelling of unbound and total plasma concentrations of paclitaxel in cancer patients. Eur J Cancer 39(8):1105-1114
56. Bissett D, Setanoians A, Cassidy J et al (1993) Phase I and pharmacokinetic study of taxotere (RP 56976) administered as a 24-hour infusion. Cancer Res 53:523-527
57. Extra JM, Rousseau F, Bruno R et al (1993) Phase I and pharmacokinetic study of taxotere (RP 56976; NSC 628503) administered as a short intravenous infusion. Cancer Res 53:1037-1042
58. Tomiak E, Piccart MJ, Kerger J et al (1994) Phase I study of docetaxel administered as a 1-hour intravenous infusion on a weekly basis. J Clin Oncol 12:1458-1467
59. Leveque D, Jehl F (1996) Clinical pharmacokinetics of vinorelbine. Clin Pharmacokinet 31(3):184-197
60. Leveque D, Quoix E, Dumont P et al (1993) Pulmonary distribution of vinorelbine in patients with non-small-cell lung cancer. Cancer Chemother Pharmacol 33:176-178
61. Zorza G, Guyomard C, Joly B et al (2000) In vitro metabolism of vinorelbine in rat, dog, and human. Proceedings of MDO 2000; Abstract 197, Stresa, Italy
62. Grudé P, Ratanasavanh D, Riché D et al (2000) Characterization of human cytochromes P450 isoenzymes involved in vinorelbine metabolism. Proceedings of MDO 2000; Abstract 179, Stresa, Italy
63. 3H-vinorelbine following IV and oral administration to patients. Proceedings of AACR 2001; Abstract 2064, New Orleans, USA
64. Soudon J, Zorza G, Van Heugen JC et al (2001) Search for vinorelbine metabolite activity: an in vitro cytotoxicity study using human ovary and lung cancer cell lines. Proceedings of AACR 2001; Abstract 2909, New Orleans, USA
65. Puozzo C, Zorza G, Guimbaud R et al (2000) Metabolism of vinorelbine in human: clinical application. Proceedings of AACR 2000; Abstract 1781, San Francisco, USA
66. Jehl F, Debs J (1990) Determination of navelbine and desacetyl-navelbine in biological fluids by high-performance liquid chromatography. J Chromatogr 525:225-233
67. Puozzo C, Gridelli C, Riggi M et al (2003) NSCLC in elderly patients: influence of age on NVB oral pharmacokinetics. Proceedings of AACR 2003; Abstract 920, Washington, USA
68. Puozzo C, Gridelli C, Jaworski M (2002) Pharmacokinetics of navelbine oral in elderly patients. Tumori 88(Suppl 1):75-76
69. Gridelli C, Guida C, Barletta E et al (2000) Thoracic radiotherapy and daily vinorelbine as radiosensitizer in locally advanced non-small cell lung cancer: a phase I study. Lung Cancer 29(2):131-137
70. Khayat D, Covelli A, Variol P et al (1995) Phase I and pharmacologic study of intravenous (Iv) vinorelbine in patients (PTS) with solid tumors. Proceedings of ASCO 1995; Abstract 1518, Los Angeles, USA
71. Urien S, Bree F, Breillout F et al (1993) Vinorelbine high affinity binding to human platelets and lymphocytes: distribution in human blood. Cancer Chemother Pharmacol 32:231-234
72. Marty M, Fumoleau P, Adenis A et al (2001) Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumours. Ann Oncol 12(11):1643-1649
73. Variol P, Bonneterre J, Marty M et al (2001) Pharmacokinetic/ pharmacodynamic relationships of IV and oral Navelbine in phase I patients. Proceedings of ASCO 2001; Abstract 435, San Francisco, USA