Medicinal cannabis does not influence the clinical pharmacokinetics of irinotecan and docetaxel

Oncologist

Volumn 12, Issue 3, 2007, Pages 291-300

  Engels, Frederike K ^a   De Jong, Floris A ^a   Sparreboom, Alex ^a,b   Mathot, Ron A A ^a   Loos, Walter J ^a   Kitzen, Jos J E M ^a   De Bruijn, Peter ^a   Verweij, Jaap ^a   Mathijssen, Ron H J ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

Author keywords

CYP3A; Docetaxel; Drug interaction; Irinotecan; Medicinal cannabis; Pharmacokinetics

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; 7 ETHYL 10 HYDROXYCAMPTOTHECIN GLUCURONIDE; ATROPINE; BEDROCAN; CANNABIS; CYTOCHROME P450 3A; DEXAMETHASONE; DOCETAXEL; GRANISETRON; IRINOTECAN; PLANT EXTRACT; UNCLASSIFIED DRUG;

ACUTE CHOLINERGIC SYNDROME; ADULT; AGED; ALLERGIC REACTION; AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG TRANSFORMATION; DRUG WITHDRAWAL; EDEMA; FATIGUE; FEMALE; HALF LIFE TIME; HEADACHE; HUMAN; LEUKOPENIA; LIVER FUNCTION; MALE; METASTASIS; MOOD DISORDER; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; PRIORITY JOURNAL; SIDE EFFECT; TEA; UNPLEASANT DREAM; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AREA UNDER CURVE; CAMPTOTHECIN; CANNABINOIDS; CYTOCHROME P-450 CYP3A; DRUG INTERACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; STATISTICS, NONPARAMETRIC; TAXOIDS;

EID: 34147104462     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.12-3-291     Document Type: Article

References (58)

1. Abel EL. Marijuana: The First Twelve Thousand Years. New York: Plenum Press, 1980:1-289.
2. Zajicek J, Fox P, Sanders H et al. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): Multicentre randomised placebo-controlled trial. Lancet 2003;362:1517-1526.
3. Beal JE, Olson R, Laubenstein L et al. Dronabinol as a treatment for anorexia associated with weight loss in patients with AIDS. J Pain Symptom Manage 1995;10:89-97.
4. Walsh D, Nelson KA, Mahmoud FA. Established and potential therapeutic applications of cannabinoids in oncology. Support Care Cancer 2003;11:137-143.
5. Tramer MR, Carroll D, Campbell FA et al. Cannabinoids for control of chemotherapy induced nausea and vomiting: Quantitative systematic review. BMJ 2001;323:16-21.
6. Jatoi A, Windschitl HE, Loprinzi CL et al. Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: A North Central Cancer Treatment Group study. J Clin Oncol 2002;20:567-573.
7. Meiri E, Jhangiani H, Vredenburgh J et al. Dronabinol treatment of delayed chemotherapy-induced nausea and vomiting. Proc Am Soc Clin Oncol 2005;24:8018a.
8. de Jong FA, Engels FK, Mathijssen RH et al. Medicinal cannabis in oncology practice: Still a bridge too far? J Clin Oncol 2005;23:2886-2891.
9. Corey S. Recent developments in the therapeutic potential of cannabinoids. P R Health Sci J 2005;24:19-26.
10. Elsohly MA, Slade D. Chemical constituents of marijuana: The complex mixture of natural cannabinoids. Life Sci 2005;78:539-548.
11. Wilkinson JD, Whalley BJ, Baker D et al. Medicinal cannabis: Is delta9-tetrahydrocannabinol necessary for all its effects? J Pharm Pharmacol 2003;55:1687-1694.
12. Williamson EM. Synergy and other interactions in phytomedicines. Phytomedicine 2001;8:401-409.
13. Ware MA, Adams H, Guy GW. The medicinal use of cannabis in the UK: Results of a nationwide survey. Int J Clin Pract 2005;59:291-295.
14. Scholten WK. Dutch measures to control medical grade marijuana: Facilitating clinical trials. Drug Inf J 2001;35:481-484.
15. Ministry of Health Welfare and Sports the Netherlands: Office of Medicinal Cannabis. Medicinal Cannabis: Information for Health Care Professionals (version date 15 March 2004). Available at http://www. cannabisbureau.nl/pdf/basic%20text%20cannabis%20EN%20vs%2015%20Mar%2004%20.pdf. Accessed January 19, 2007.
16. Sparreboom A, Cox MC, Acharya MR et al. Herbal remedies in the United States: Potential adverse interactions with anticancer agents. J Clin Oncol 2004;22:2489-2503.
17. Tascilar M, de Jong FA, Verweij J et al. Complementary and alternative medicine during cancer treatment: Beyond innocence. The Oncologist 2006;11:732-741.
18. Kehrer DF, Mathijssen RH, Verweij J et al. Modulation of irinotecan metabolism by ketoconazole. J Clin Oncol 2002;20:3122-3129.
19. Mathijssen RH, Verweij J, de Bruijn P et al. Effects of St. John's wort on irinotecan metabolism. J Natl Cancer Inst 2002;94:1247-1249.
20. Engels FK, Ten Tije AJ, Baker SD et al. Effect of cytochrome P450 3A4 inhibition on the pharmacokinetics of docetaxel. Clin Pharmacol Ther 2004;75:448-454.
21. Lepper ER, Baker SD, Permenter M et al. Effect of common CYP3A4 and CYP3A5 variants on the pharmacokinetics of the cytochrome P450 3A phenotyping probe midazolam in cancer patients. Clin Cancer Res 2005;11:7398-7404.
22. Bornheim LM, Correia MA. Selective inactivation of mouse liver cytochrome P-450IIIA by cannabidiol. Mol Pharmacol 1990;38:319-326.
23. Yamamoto I, Watanabe K, Narimatsu S et al. Recent advances in the metabolism of cannabinoids. Int J Biochem Cell Biol 1995;27:741-746.
24. Bornheim LM, Everhart ET, Li J et al. Characterization of cannabidiolmediated cytochrome P450 inactivation. Biochem Pharmacol 1993;45:1323-1331.
25. Jaeger W, Benet LZ, Bornheim LM. Inhibition of cyclosporine and tetrahydrocannabinol metabolism by cannabidiol in mouse and human microsomes. Xenobiotica 1996;26:275-284.
26. Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet 2003;42:327-360.
27. Bornheim LM, Everhart ET, Li J et al. Induction and genetic regulation of mouse hepatic cytochrome P450 by cannabidiol. Biochem Pharmacol 1994;48:161-171.
28. McLeod AL, McKenna CJ, Northridge DB. Myocardial infarction following the combined recreational use of Viagra and cannabis. Clin Cardiol 2002;25:133-134.
29. Kosel BW, Aweeka FT, Benowitz NL et al. The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir. AIDS 2002;16:543-550.
30. Kalant H. Medicinal use of cannabis: History and current status. Pain Res Manag 2001;6:80-91.
31. Riggs CE Jr., Egorin MJ, Fuks JZ et al. Initial observations on the effects of delta 9-tetrahydrocannabinol on the plasma pharmacokinetics of cyclophosphamide and doxorubicin. J Clin Pharmacol 1981;21(8-9 suppl):90S-98S.
32. Shou M, Martinet M, Korzekwa KR et al. Role of human cytochrome P450 3A4 and 3A5 in the metabolism of Taxotere and its derivatives: Enzyme specificity, interindividual distribution and metabolic contribution in human liver. Pharmacogenetics 1998;8:391-401.
33. Mathijssen RH, van Alphen RJ, Verweij J et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res 2001;7:2182-2194.
34. Kehrer DF, Sparreboom A, Verweij J et al. Modulation of irinotecaninduced diarrhea by cotreatment with neomycin in cancer patients. Clin Cancer Res 2001;7:1136-1141.
35. U.S. Food and Drug Administration (FDA). Guidance for Industry. In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling. Available at http://www.fda.gov/cder/ guidance/6695dft.htm. Accessed January 19, 2007.
36. 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;16:187-196.
37. Schoenfeld DA. Statistical Considerations for a Cross-Over Study. Available at http://hedwig.mgh.harvard.edu/sample_size/quan_measur/cross_quant. html. Accessed January 17, 2007.
38. Rudek MA, Sparreboom A, Garrett-Mayer ES et al. Factors affecting pharmacokinetic variability following doxorubicin and docetaxel-based therapy. Eur J Cancer 2004;40:1170-1178.
39. Mathijssen RH, Verweij J, de Jonge MJ et al. Impact of body-size measures on irinotecan clearance: Alternative dosing recommendations. J Clin Oncol 2002;20:81-87.
40. Baker SD, Verweij J, Rowinsky EK et al. Role of body surface area in dosing of investigational anticancer agents in adults, 1991-2001. J Natl Cancer Inst 2002;94:1883-1888.
41. de Jong FA, Mathijssen RH, Xie R et al. Flat-fixed dosing of irinotecan: Influence on pharmacokinetic and pharmacodynamic variability. Clin Cancer Res 2004;10:4068-4071.
42. Poujol S, Bressolle F, Duffour J et al. Pharmacokinetics and pharmacodynamics of irinotecan and its metabolites from plasma and saliva data in patients with metastatic digestive cancer receiving Folfiri regimen. Cancer Chemother Pharmacol 2006;58:292-305.
43. National Cancer Institute CTEP. Common Toxicity Criteria version 2.0. Available at http://ctep.cancer.gov/forms/CTCv20_4-30-992.pdf. Accessed January 19, 2007.
44. Engels FK, Mathot RA, Loos WJ et al. Influence of high-dose ketoconazole on the pharmacokinetics of docetaxel. Cancer Biol Ther 2006;5:833-839.
45. de Bruijn P, Verweij J, Loos WJ et al. Determination of irinotecan (CPT-11) and its active metabolite SN-38 in human plasma by reversed-phase high-performance liquid chromatography with fluorescence detection. J Chromatogr B Biomed Sci Appl 1997;698:277-285.
46. de Bruijn P, Willems EW, Loos WJ et al. Indirect determination of the irinotecan metabolite 7-ethyl-10-O-glucuronyl-camptothecin in human samples. Anal Biochem 2004;328:84-86.
47. Xie R, Mathijssen RH, Sparreboom A et al. Clinical pharmacokinetics of irinotecan and its metabolites: A population analysis. J Clin Oncol 2002;20:3293-3301.
48. de Jong FA, Scott-Horton TJ, Kroetz DL et al. Irinotecan-induced diarrhea: Functional significance of the polymorphic ABCC2 transporter protein. Clin Pharmacol Ther 2007;81:42-49.
49. Beal SL, Sheiner LB. NONMEM Users Guide. San Francisco: Division of Pharmacology, University of California, 1992:parts I-VII.
50. Yamaoka K, Nakagawa T, Uno T. Application of Akaike's information criterion (AIC) in the evaluation of linear pharmacokinetic equations. J Pharmacokinet Biopharm 1978;6:165-175.
51. Verstraete AG. Detection times of drugs of abuse in blood, urine, and oral fluid. Ther Drug Monit 2004;26:200-205.
52. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657- 680.
53. Rosing H, Lustig V, van Warmerdam LJ et al. Pharmacokinetics and metabolism of docetaxel administered as a 1-h intravenous infusion. Cancer Chemother Pharmacol 2000;45:213-218.
54. Goh BC, Lee SC, Wang LZ et al. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. J Clin Oncol 2002;20:3683-3690.
55. de Jong FA, de Jonge MJ, Verweij J et al. Role of pharmacogenetics in irinotecan therapy. Cancer Lett 2006;234:90 -106.
56. Zhu HJ, Wang JS, Markowitz JS et al. Characterization of P-glycoprotein inhibition by major cannabinoids from marijuana. J Pharmacol Exp Ther 2006;317:850-857.
57. Erkens JA, Janse AF, Herings RM. Limited use of medicinal cannabis but for labeled indications after legalization. Pharmacoepidemiol Drug Saf 2005;14:821-822.
58. Sharpe P, Smith G. Cannabis: Time for scientific evaluation of this ancient remedy? Anesth Analg 2000;90:237-240.