Phase I pharmacokinetic, food effect, and pharmacogenetic study of oral irinotecan given as semisolid matrix capsules in patients with solid tumors

Clinical Cancer Research

Volumn 11, Issue 4, 2005, Pages 1504-1511

  Soepenberg, Otto ^a   Dumez, Herlinde ^b   Verweij, Jaap ^a   De Jong, Floris A ^a   De Jonge, Maja J A ^a   Thomas, José ^b   Eskens, Ferry A L M ^a   Van Schaik, Ron H N ^a   Selleslach, Johan ^b   Ter Steeg, Judith ^a   Lefebvre, Patricia ^c   Assadourian, Sylvie ^c   Sanderink, Ger Jan ^c   Sparreboom, Alex ^a   Van Oosterom, Allan T ^b  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c SANOFI   (France)

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; IRINOTECAN; LOPERAMIDE; METOCLOPRAMIDE; SEROTONIN 3 ANTAGONIST;

ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CALORIC INTAKE; CANCER REGRESSION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE CALCULATION; DOSE LIMITING TOXICITY; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDUCED DISEASE; DRUG METABOLISM; DRUG RESPONSE; FEMALE; FEVER; FOOD DRUG INTERACTION; GENOTYPE; HUMAN; LEUKOPENIA; LIPID DIET; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NEUTROPENIA; PHARMACOGENETICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SEMISOLID MATRIX CAPSULE; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; ANEMIA; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AREA UNDER CURVE; CAMPTOTHECIN; CAPSULES; CYTOCHROME P-450 ENZYME SYSTEM; DIARRHEA; DIETARY FATS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENOTYPE; GLUCURONOSYLTRANSFERASE; HUMANS; LEUKOPENIA; MALE; MIDDLE AGED; NAUSEA; NEOPLASMS; NEUTROPENIA; POLYMORPHISM, GENETIC; PROMOTER REGIONS (GENETICS); THROMBOCYTOPENIA; TIME FACTORS; TREATMENT OUTCOME; VOMITING;

EID: 20044391814     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-04-1758     Document Type: Article

References (45)

1. Vanhoefer U, Harstrick A, Achterrath W, et al. Irinotecan in the treatment of colorectal cancer: clinical overview. J Clin Oncol 2001; 19:1501-18.
2. Shimada Y, Yoshino M, Wakui A, et al. Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. CPT-11 Gastrointestinal Cancer Study Group. J Clin Oncol 1993;11:909-13.
3. Rothenberg ML, Eckardt JR, Kuhn JG, et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol 1996;14:1128-35.
4. Pitot HC, Wender DB, O'Connell MJ, et al. Phase II trial of irinotecan in patients with metastatic colorectal carcinoma. J Clin Oncol 1997;15: 2910-19.
5. Rougier P, Bugat R, Douillard JY, et al. Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy. J Clin Oncol 1997;15:251-60.
6. Rougier P, Van Cutsem E, Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 1998;352: 1407-12.
7. Cunningham D, Pyrhonen S, James RD, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 1998;352:1413-8.
8. Rothenberg ML, Cox JV, DeVore RF, et al. A multicenter, phase II trial of weekly irinotecan (CPT-11) in patients with previously treated colorectal carcinoma. Cancer 1999;85:786-95.
9. 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 (5-FU). Eur J Cancer 1999;35:54-9.
10. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000;355:1041-7.
11. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000;343:905-14.
12. Kawato Y, Aonuma M, Hirota Y, et al. Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res 1991;51:4187-91.
13. Iyer L, King CD, Whitington PF, et al. Genetic predisposition to the metabolism of irinotecan (CPT-11). Role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN-38) in human liver microsomes. J Clin Invest 1998; 101:847-54.
14. Ando Y, Saka H, Ando M, et al. Polymorphisms of UDP- glucuronosyltransferase gene and irinotecan toxicity: a pharmacogenetic analysis. Cancer Res 2000;60:6921-6.
15. Iyer L, Das S, Janisch L, et al. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J 2002;2:43-7.
16. Santos A, Zanetta S, Cresteil T, et al. Metabolism of irinotecan (CPT-11) by CYP3A4 and CYP3A5 in humans. Clin Cancer Res 2000; 6:2012-20.
17. Mathijssen RH, van Alphen RJ, Verweij J, et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res 2001;7:2182-94.
18. Sparreboom A, Danesi R, Ando Y, et al. Pharmacogenomics of ABC transporters and its role in cancer chemotherapy. Drug Resist Updat 2003;6:71-84.
19. Sugiyama Y, Kato Y, Chu X. Multiplicity of biliary excretion mechanisms for the camptothecin derivative irinotecan (CPT-11), its metabolite SN-38, and its glucuronide: role of canalicular multispecific organic anion transporter and P-glycoprotein. Cancer Chemother Pharmacol 1998;42:S44-9.
20. Drengler RL, Kuhn JG, Schaaf LJ, et al. Phase I and pharmacokinetic trial of oral irinotecan administered daily for 5 days every 3 weeks in patients with solid tumors. J Clin Oncol 1999;17:685-96.
21. Guidance for industry, food-effect bioavailability and fed bioequivalence studies (http://www.fda.gov/cder/guidance/5194fnl.pdf).
22. Dumez H, Awada A, van Oosterom A, et al. A phase I and pharmacokinetic trial of oral formulation of irinotecan administered daily for 5 days every 3 weeks in patients with solid tumours [abstract]. Proc Am Soc Clin Oncol 2001;20:103a.
23. National Cancer Institute. Guidelines for reporting of adverse drug reactions. Bethesda (MD): National Cancer Institute, 1988.
24. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-16.
25. Hoffmeyer S, Burk O, von Richter O, et al. Functional polymorphisms of the human multidrug-resistance gene: multiple sequence variations and correlation of one allele with P-glycoprotein expression and activity in vivo. Proc Natl Acad Sci U S A 2000;97:3473-8.
26. van Schaik RHN, van der Heiden IP, van den Anker JN, et al. CYP3A5 variant allele frequencies in Dutch Caucasians. Clin Chem 2002;48:1668-71.
27. Hesselink DA, van Schaik RHN, van der Heiden IP, et al. Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus. Clin Pharmacol Ther 2003;74:245-54.
28. Chabot GG. Clinical pharmacokinetics of irinotecan. Clin Pharmacokinet 1997;33:245-59.
29. Mathijssen RH, Marsh S, Karlsson MO, et al. Irinotecan pathway genotype analysis to predict pharmacokinetics. Clin Cancer Res 2003;9:3246-53.
30. Dai D, Tang J, Rose R, et al. Identification of variants of CYP3A4 and characterization of their abilities to metabolize testosterone and chlorpyrifos. J Pharmacol Exp Ther 2001;299:825-31.
31. Saliba F, Hagipantelli R, Misset JL, et al. Pathophysiology and therapy of irinotecan-induced delayed-onset diarrhea in patients with advanced colorectal cancer: a prospective assessment. J Clin Oncol 1998;16:2745-51.
32. Pitot HC, Adjei AA, Reid JM, et al. A phase I and pharmacokinetic study of a powder-filled capsule (PFC) formulation of oral irinotecan (CPT-11) given daily for 5 days every 3 weeks in patients with advanced solid tumors [abstract]. Proc Am Soc Clin Oncol 2001;20: 102a.
33. Schoemaker NE, ten Bokkel Huinink WW, Vemillet L, et al. A phase I and pharmacokinetic trial of oral formulation of irinotecan administered daily for 14 days every 3 weeks in patients with solid tumours [abstract]. Proc Am Soc Clin Oncol 2001;20:75a.
34. Sharma S, Knight RD, Hollywood E, et al. A phase I and pharmacokinetic study of powder-filled capsule formulation of oral irinotecan (CPT-11) given daily for 14 days every 3 weeks in patients with advanced solid tumors [abstract]. Proc Am Soc Clin Oncol 2001;20:103a.
35. Berlin J, Benson AB, Rubin E, et al. Phase I safety, pharmacokinetic, and bioavailability study of a Semi-Solid Matrix formulation of oral irinotecan in patients with advanced solid tumors [abstract]. Proc Am Soc Clin Oncol 2003;22:130.
36. Khanna R, Morton CL, Danks MK, et al. Proficient metabolism of irinotecan by a human intestinal carboxylesterase. Cancer Res 2000;60: 4725-8.
37. 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;84:972-4.
38. Herben VM, Schellens JH, Swart M, et al. Phase I and pharmacokinetic study of irinotecan administered as a low-dose, continuous intravenous infusion over 14 days in patients with malignant solid tumors. J Clin Oncol 1999;17:1897-905.
39. Kaneda N, Nagata H, Furuta T, et al. Metabolism and pharmacokinetics of the camptothecin analogue CPT-11 in the mouse. Cancer Res 1990;50:1715-20.
40. Kaneda N, Yokokura T. Nonlinear pharmacokinetics of CPT-11 in rats. Cancer Res 1990;50:1721-5.
41. Houghton PJ, Cheshire PJ, Hallman JD, et al. Efficacy of topoisomerase I inhibitors, topotecan and irinotecan, administered at low-dose levels in protracted schedules to mice bearing xenografts of human tumors. Cancer Chemother Pharmacol 1995;36:393-403.
42. Abigerges D, Chabot GG, Armand JP, et al. Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 1995; 13:210-21.
43. Gupta E, Mick R, Ramirez J, et al. Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. J Clin Oncol 1997;15:1502-10.
44. Innocenti F, Undevia SD, Iyer L, et al. UGT1A1*28 polymorphism is a predictor of neutropenia in irinotecan chemotherapy [abstract]. Proc Am Soc Clin Oncol 2003;22:124.
45. Innocenti F, Grimsley C, Das S, et al. Haplotype structure of the UDP-glucuronosyltransferase 1A1 promoter in different ethnic groups. Pharmacogenetics 2002;12:725-33.