Comparative Pharmacokinetics of Weekly and Every-Three-Weeks Docetaxel

Clinical Cancer Research

Volumn 10, Issue 6, 2004, Pages 1976-1983

  Baker, Sharyn D ^a   Zhao, Ming ^a   Lee, Carlton K K ^a   Verweij, Jaap ^b   Zabelina, Yelena ^a   Brahmer, Julie R ^a   Wolff, Antonio C ^a   Sparreboom, Alex ^b,c   Carducci, Michael A ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; DOXORUBICIN; IRINOTECAN;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; FEMALE; HUMAN; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MICROTUBULE; PRIORITY JOURNAL; RADIOSENSITIVITY; TUMOR VASCULARIZATION;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; NEOPLASMS; TAXOIDS;

EID: 1642402252     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-0842-03     Document Type: Article

References (54)

1. Crown J, Dieras V, Kaufmann M, et al. Chemotherapy for metastatic breast cancer-report of a European expert panel. Lancet Oncol 2002;3: 719-27.
2. Green MR. Perspectives and opportunities: docetaxel in the current and future treatment of non-small cell lung cancer. Semin Oncol 2002; 29:17-21.
3. Hortobagyi GN, Kris MG. Expanding horizons: an update on the use of docetaxel in non-small cell lung, ovarian, and breast cancers. Semin Oncol 2002;29:1-3.
4. Kaye SB, Vasey PA. Docetaxel in ovarian cancer: Phase III perspectives and future development. Semin Oncol 2002;29:22-7.
5. Bruno R, Hille D, Riva A, et al. Population pharmacokinetics/pharmacodynamics of docetaxel in Phase II studies in patients with cancer. J Clin Oncol 1998;16:187-96.
6. Burstein HJ, Manola J, Younger J, et al. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 2000;18: 1212-9.
7. Hainsworth JD, Burris HA 3rd, Litchy S, et al. Weekly docetaxel in the treatment of elderly patients with advanced nonsmall cell lung carcinoma. A Minnie Pearl Cancer Research Network Phase II Trial. Cancer (Phila.) 2000;89:328-33.
8. Graziano F, Catalano V, Baldelli AM, et al. A Phase II study of weekly docetaxel as salvage chemotherapy for advanced gastric cancer. Ann Oncol 2000;11:1263-6.
9. Hainsworth JD, Burris HA 3rd, Yardley DA, et al. Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network Phase II trial. J Clin Oncol. 2001;19:3500-5.
10. Lilenbaum RC, Schwartz MA, Seigel L, et al. Phase II trial of weekly docetaxel in second-line therapy for nonsmall cell lung carcinoma. Cancer (Phila.) 2001;92:2158-63.
11. Beer TM, Pierce WC, Lowe BA, Henner WD. Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol 2001;12:1273-9.
12. Stemmler HJ, Gutschow K, Sommer H, et al. Weekly docetaxel (Taxotere) in patients with metastatic breast cancer. Ann Oncol 2001; 12:1393-8.
13. Berry W, Dakhil S, Gregurich MA, Asmar L. Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of the prostate. Semin Oncol 2001;28:8-15.
14. Valerio MR, Russo A, Latteri MA, et al. Weekly docetaxel as II line therapy in non-small cell lung cancer: an interim analysis of a Phase II study. Lung Cancer 2001;34(Suppl 4):S31-5.
15. Mey U, Gorschluter M, Ziske C, Kleinschmidt R, Glasmacher A, Schmidt-Wolf IG. Weekly docetaxel in patients with pretreated metastatic breast cancer: a Phase II trial. Anticancer Drugs 2003;14:233-8.
16. Aihara T, Kim Y, Takatsuka Y. Phase II study of weekly docetaxel in patients with metastatic breast cancer. Ann Oncol 2002;13:286-92.
17. Schutte W, Nagel S, Lautenschlager C, Wollschlager B, Serke M. Randomized phase III study of weekly versus three-weekly docetaxel as second-line chemotherapy for advanced non-small cell lung cancer. Proc Am Soc Clin Oncol 2002;21:308a.
18. Kuroi K, Bando H, Saji S, Toi M. Weekly schedule of docetaxel in breast cancer: evaluation of response and toxicity. Breast Cancer 2003; 10:10-4.
19. Zimatore M, Danova M, Vassallo E, et al. Weekly taxanes in metastatic breast cancer. Oncol Rep 2002;9:1047-52.
20. Climent MA, Tabernero J, Albanell J, et al. Preliminary results of a Phase II randomized trial of docetaxel (Taxotere) as a single agent chemotherapy (CT) administered weekly or 3-weekly in patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2002; 21:52a.
21. 2 weekly in patients with pretreated non small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 2002;21:10a.
22. Vergniol JC, Bruno R, Montay G, Frydman A. Determination of Taxotere in human plasma by a semi-automated high-performance liquid chromatographic method. J Chromatogr 1992;582:273-8.
23. Loos WJ, Verweij J, Nooter K, Stoter G, Sparreboom A. Sensitive determination of docetaxel in human plasma by liquid-liquid extraction and reversed-phase high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1997;693:437-41.
24. Rosing H, Lustig V, Koopman FP, ten Bokkel Huinink WW, Beijnen JH. Bio-analysis of docetaxel and hydroxylated metabolites in human plasma by high-performance liquid chromatography and automated solid-phase extraction. J Chromatogr B Biomed Sci Appl 1997; 696:89-98.
25. Rouini MR, Lotfolahi A, Stewart DJ, et al. A rapid reversed phase high performance liquid chromatographic method for the determination of docetaxel (Taxotere) in human plasma using a column switching technique. J Pharm Biomed Anal 1998;17:1243-7.
26. Ardiet CJ, Tranchand B, Zanetta S, et al. A sensitive docetaxel assay in plasma by solid-phase extraction and high performance liquid chromatography-UV detection: validation and suitability in Phase I clinical trial pharmacokinetics. Investig New Drugs 1999;17:325-33.
27. Garg MB, Ackland SP. Simple and sensitive high-performance liquid chromatography method for the determination of docetaxel in human plasma or urine. J Chromatogr B Biomed Sci Appl 2000;748: 383-8.
28. Ciccolini J, Catalin J, Blachon MF, Durand A. Rapid high-performance liquid chromatographic determination of docetaxel (Taxotere) in plasma using liquid-liquid extraction. J Chromatogr B Biomed Sci Appl 2001;759:299-306.
29. Parise RA, Ramanathan RK, Zamboni WC, Egorin MJ. Sensitive liquid chromatography-mass spectrometry assay for quantitation of docetaxel and paclitaxel in human plasma. J Chromatogr B Anal Technol Biomed Life Sci 2003;783:231-6.
30. D'Argenio DZ, Schumitzky A. A program package for simulation and parameter estimation in pharmacokinetics. Comput Methods Programs Biomed 1979;9:115-34.
31. Yamaoka K, Nakagawa T, Uno T. Application of Akaike's information criterion (AIC) in the evaluation of linear pharmacokinetic equations. J Pharmacokinet Biopharm 1978;6:165-75.
32. Adjei AA, Klein CE, Kastrissios H, et al. Phase I and pharmacokinetic study of irinotecan and docetaxel in patients with advanced solid tumors: preliminary evidence of clinical activity. J Clin Oncol 2000;18: 1116-23.
33. Couteau C, Risse ML, Ducreux M, et al. Phase I and pharmacokinetic study of docetaxel and irinotecan in patients with advanced solid tumors. J Clin Oncol 2000;18:3545-52.
34. Bruno R, Vivier N, Veyrat-Follet C, Montay G, Rhodes GR. Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Investig New Drugs 2001;19:163-9.
35. Clarke SJ, Rivory LP. Clinical pharmacokinetics of docetaxel. Clin Pharmacokinet 1999;36:99-114.
36. Loos WJ, Baker SD, Verweij J, Boonstra JG, Sparreboom A. Clinical pharmacokinetics of unbound docetaxel: role of polysorbate 80 and serum proteins. Clin Pharmacol Ther 2003;74:364-71.
37. Sparreboom A, Zhao M, Brahmer JR, Verweij J, Baker SD. Determination of the docetaxel vehicle, polysorbate 80, in patient samples by liquid chromatography-tandem mass spectrometry. J Chromatogr B Anal Technol Biomed Life Sci 2002;773:183-90.
38. Urien S, Barre J, Morin C, Paccaly A, Montay G, Tillement JP. Docetaxel serum protein binding with high affinity to α1-acid glycoprotein. Investig New Drugs 1996;14:147-51.
39. van Tellingen O, Beijnen JH, Verweij J, Scherrenburg EJ, Nooijen WJ, Sparreboom A. Rapid esterase-sensitive breakdown of polysorbate 80 and its impact on the plasma pharmacokinetics of docetaxel and metabolites in mice. Clin Cancer Res 1999;5:2918-24.
40. Bissery MC, Nohynek G, Sanderink GJ, Lavelle F. Docetaxel (Taxotere): a review of preclinical and clinical experience. Part I: preclinical experience. Anticancer Drugs 1995;6:339-55, 363-8.
41. Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, et al. European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J Clin Oncol 1994;12:2654-66.
42. Nabholtz JM, Gelmon K, Bontenbal M, et al. Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol 1996;14:1858-67.
43. Winer EP, Berry D, Duggan D, et al. Failure of higher dose paclitaxel to improve outcome in patients with metastatic breast cancer-results from CALGB 9342. Proc Am Soc Clin Oncol 1998;17:101a.
44. Jordan MA, Toso RJ, Thrower D, Wilson L. Mechanism of mitotic block and inhibition of cell proliferation by taxol at low concentrations. Proc Natl Acad Sci USA 1993;90:9552-6.
45. 2 arrest instead of mitotic arrest: molecular determinants of paclitaxel-induced cytotoxicity. Oncogene 2001;20:3806-13.
46. Yvon AM, Wadsworth P, Jordan MA. Taxol suppresses dynamics of individual microtubules in living human tumor cells. Mol Biol Cell 1999;10:947-59.
47. Sweeney CJ, Miller KD, Sissons SE, et al. The antiangiogenic property of docetaxel is synergistic with a recombinant humanized monoclonal antibody against vascular endothelial growth factor or 2-methoxyestradiol but antagonized by endothelial growth factors. Cancer Res 2001;61:3369-72.
48. Hotchkiss KA, Ashton AW, Mahmood R, Russell RG, Sparano JA, Schwartz EL. Inhibition of endothelial cell function in vitro and angiogenesis in vivo by docetaxel (Taxotere): association with impaired repositioning of the microtubule organizing center. Mol Cancer Ther 2002;1:1191-200.
49. Vacca A, Ribatti D, Iurlaro M, et al. Docetaxel versus paclitaxel for antiangiogenesis. J Hematother Stem Cell Res 2002;11:103-18.
50. Choy H. Taxanes in combined modality therapy for solid tumors. Crit Rev Oncol Hematol 2001;37:237-47.
51. Grant DS, Williams TL, Zahaczewsky M, Dicker AP. Comparison of antiangiogenic activities using paclitaxel (taxol) and docetaxel (Taxotere). Int J Cancer 2003;104:121-9.
52. Avramis IA, Kwock R, Avramis VI. Taxotere and vincristine inhibit the secretion of the angiogenesis inducing vascular endothelial growth factor (VEGF) by wild-type and drug-resistant human leukemia T-cell lines. Anticancer Res 2001;21:2281-6.
53. Fennelly D, Aghajanian C, Shapiro F, et al. Phase I and pharmacologic study of paclitaxel administered weekly in patients with relapsed ovarian cancer. J Clin Oncol 1997;15:187-92.
54. Socinski MA, Schell MJ, Bakri K, et al. Second-line, low-dose, weekly paclitaxel in patients with stage IIIB/IV nonsmall cell lung carcinoma who fail first-line chemotherapy with carboplatin plus paclitaxel. Cancer 2002;95:1265-73.