Phase I dosage finding and pharmacokinetic study of intravenous topotecan and oral erlotinib in adults with refractory solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 73, Issue 3, 2014, Pages 561-568

  Stewart, Clinton F ^a   Tagen, Michael ^a   Schwartzberg, Lee S ^b   Blakely, L Johnetta ^b   Tauer, Kurt W ^b   Smiley, Linda M ^b  

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

^b WEST CLINIC   (United States)

Author keywords

Clinical trial; Erlotinib; Pharmacokinetics; Refractory solid tumors; Topotecan

Indexed keywords

BREAST CANCER RESISTANCE PROTEIN; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; ERLOTINIB; GLUCURONOSYLTRANSFERASE 1A1; MULTIDRUG RESISTANCE PROTEIN; TOPOTECAN;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; COLORECTAL CANCER; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; GENETIC ASSOCIATION; GENETIC POLYMORPHISM; HUMAN; HYPOTENSION; KIDNEY CLEARANCE; MALE; MIDDLE AGED; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OPEN STUDY; OVARY CANCER; OVERALL SURVIVAL; PATIENT HISTORY OF CHEMOTHERAPY; PHARMACOGENETICS; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SOLID TUMOR; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE;

ADMINISTRATION, INTRAVENOUS; ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG ADMINISTRATION SCHEDULE; GENOTYPE; HUMANS; MIDDLE AGED; NEOPLASMS; PHARMACOGENETICS; QUINAZOLINES; TOPOTECAN;

EID: 84896056605     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-014-2385-0     Document Type: Article

References (38)

1. Pizzolato JF, Saltz LB (2003) The camptothecins. Lancet 361(9376):2235-2242. doi:10.1016/S0140-6736(03)13780-4 (Pubitemid 36782561)
2. Simon GR, Wagner H (2003) Small cell lung cancer. Chest 123(1 Suppl):259S-271S (Pubitemid 36138804)
3. Kruijtzer CM, Beijnen JH, Rosing H, ten Bokkel Huinink WW, Schot M, Jewell RC, Paul EM, Schellens JH (2002) Increased oral bioavailability of topotecan in combination with the breast cancer resistance protein and P-glycoprotein inhibitor GF120918. J Clin Oncol 20(13):2943-2950 (Pubitemid 34728888)
4. Diestra JE, Scheffer GL, Catala I, Maliepaard M, Schellens JH, Scheper RJ, Germa-Lluch JR, Izquierdo MA (2002) Frequent expression of the multi-drug resistance-associated protein BCRP/MXR/ABCP/ABCG2 in human tumours detected by the BXP-21 monoclonal antibody in paraffin-embedded material. J Pathol 198(2):213-219. doi:10.1002/path.1203 (Pubitemid 35243879)
5. Tian Q, Zhang J, Chan SY, Tan TM, Duan W, Huang M, Zhu YZ, Chan E, Yu Q, Nie YQ, Ho PC, Li Q, Ng KY, Yang HY, Wei H, Bian JS, Zhou SF (2006) Topotecan is a substrate for multidrug resistance associated protein 4. Curr Drug Metab 7(1):105-118
6. Gottesman MM, Fojo T, Bates SE (2002) Multidrug resistance in cancer: role of ATP-dependent transporters. Nat Rev Cancer 2(1):48-58. doi:10.1038/nrc706 (Pubitemid 37328807)
7. Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W (2007) Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 25(15):1960-1966. doi:10.1200/JCO.2006.07.9525 (Pubitemid 46972777)
8. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L (2005) Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353(2):123-132. doi:10.1056/NEJMoa050753 (Pubitemid 41058344)
9. Rosell R, Moran T, Carcereny E, Quiroga V, Molina MA, Costa C, Benlloch S, Taron M (2010) Non-small-cell lung cancer harbouring mutations in the EGFR kinase domain. Clin Transl Oncol 12(2):75-80
10. Saif MW Colorectal cancer in review: the role of the EGFR pathway. Expert Opin Investig Drugs 19(3):357-369. doi:10.1517/13543781003593962
11. Milanezi F, Carvalho S, Schmitt FC (2008) EGFR/HER2 in breast cancer: a biological approach for molecular diagnosis and therapy. Expert Rev Mol Diagn 8(4):417-434. doi:10.1586/14737159.8.4.417 (Pubitemid 351962088)
12. Papageorgio C, Perry MC (2007) Epidermal growth factor receptor-targeted therapy for pancreatic cancer. Cancer Invest 25(7):647-657. doi:10.1080/ 07357900701522653 (Pubitemid 350135745)
13. Lafky JM, Wilken JA, Baron AT, Maihle NJ (2008) Clinical implications of the ErbB/epidermal growth factor (EGF) receptor family and its ligands in ovarian cancer. Biochim Biophys Acta 1785(2):232-265. doi:10.1016/j.bbcan.2008. 01.001
14. Molinolo AA, Amornphimoltham P, Squarize CH, Castilho RM, Patel V, Gutkind JS (2009) Dysregulated molecular networks in head and neck carcinogenesis. Oral Oncol 45(4-5):324-334. doi:10.1016/j.oraloncology.2008.07. 011
15. Pande AU, Iyer RV, Rani A, Maddipatla S, Yang GY, Nwogu CE, Black JD, Levea CM, Javle MM (2007) Epidermal growth factor receptor-directed therapy in esophageal cancer. Oncology 73(5-6):281-289. doi:10.1159/000132393 (Pubitemid 351862017)
16. El-Jawahri A, Patel D, Zhang M, Mladkova N, Chakravarti A (2008) Biomarkers of clinical responsiveness in brain tumor patients: progress and potential. Mol Diagn Ther 12(4):199-208
17. Soulieres D, Senzer NN, Vokes EE, Hidalgo M, Agarwala SS, Siu LL (2004) Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J Clin Oncol 22(1):77-85. doi:10.1200/JCO.2004.06.075 (Pubitemid 41095117)
18. Gordon AN, Finkler N, Edwards RP, Garcia AA, Crozier M, Irwin DH, Barrett E (2005) Efficacy and safety of erlotinib HCl, an epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor, in patients with advanced ovarian carcinoma: results from a phase II multicenter study. Int J Gynecol Cancer 15(5):785-792. doi:10.1111/j.1525-1438.2005.00137.x (Pubitemid 41783082)
19. Dickler MN, Cobleigh MA, Miller KD, Klein PM, Winer EP (2009) Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Res Treat 115(1):115-121. doi:10.1007/s10549-008-0055-9
20. Townsley CA, Major P, Siu LL, Dancey J, Chen E, Pond GR, Nicklee T, Ho J, Hedley D, Tsao M, Moore MJ, Oza AM (2006) Phase II study of erlotinib (OSI-774) in patients with metastatic colorectal cancer. Br J Cancer 94(8):1136-1143. doi:10.1038/sj.bjc.6603055
21. Shi Z, Peng XX, Kim IW, Shukla S, Si QS, Robey RW, Bates SE, Shen T, Ashby CR Jr, Fu LW, Ambudkar SV, Chen ZS (2007) Erlotinib (Tarceva, OSI-774) antagonizes ATP-binding cassette subfamily B member 1 and ATP-binding cassette sub-family G member 2-mediated drug resistance. Cancer Res 67(22):11012-11020 (Pubitemid 350145931)
22. Carcaboso AM, Elmeliegy MA, Shen J, Juel SJ, Zhang ZM, Calabrese C, Tracey L, Waters CM, Stewart CF (2010) Tyrosine kinase inhibitor gefitinib enhances topotecan penetration of gliomas. Cancer Res 70(11):4499-4508. doi:10.1158/0008-5472.CAN-09-4264
23. Shen J, Carcaboso AM, Hubbard KE, Tagen M, Wynn HG, Panetta JC, Waters CM, Elmeliegy MA, Stewart CF (2009) Compartment-specific roles of ATP-binding cassette transporters define differential topotecan distribution in brain parenchyma and cerebrospinal fluid. Cancer Res 69(14):5885-5892. doi:10.1158/0008-5472.CAN-09-0700
24. Rowinsky EK, Grochow LB, Hendricks CB, Ettinger DS, Forastiere AA, Hurowitz LA, McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SH et al (1992) Phase I and pharmacologic study of topotecan: a novel topoisomerase I inhibitor. J Clin Oncol 10:647-656
25. Kadlubar FF, Berkowitz GS, Delongchamp RR, Wang C, Green BL, Tang G, Lamba J, Schuetz E, Wolff MS (2003) The CYP3A4*1B variant is related to the onset of puberty, a known risk factor for the development of breast cancer. Cancer Epidemiol Biomark Prev 12(4):327-331 (Pubitemid 36427993)
26. Lee SJ, Goldstein JA (2005) Functionally defective or altered CYP3A4 and CYP3A5 single nucleotide polymorphisms and their detection with genotyping tests. Pharmacogenomics 6(4):357-371
27. Zheng H, Webber S, Zeevi A, Schuetz E, Zhang J, Lamba J, Bowman P, Burckart GJ (2002) The MDR1 polymorphisms at exons 21 and 26 predict steroid weaning in pediatric heart transplant patients. Hum Immunol 63(9):765-770 (Pubitemid 34983308)
28. Zamber CP, Lamba JK, Yasuda K, Farnum J, Thummel K, Schuetz JD, Schuetz EG (2003) Natural allelic variants of breast cancer resistance protein (BCRP) and their relationship to BCRP expression in human intestine. Pharmacogenetics 13(1):19-28 (Pubitemid 36135683)
29. Poonkuzhali B, Lamba J, Strom S, Sparreboom A, Thummel K, Watkins P, Schuetz E (2008) Association of breast cancer resistance protein/ABCG2 phenotypes and novel promoter and intron 1 single nucleotide polymorphisms. Drug Metab Dispos 36(4):780-795. doi:10.1124/dmd.107.018366 (Pubitemid 351468386)
30. Turner PK, Iacono LC, Panetta JC, Santana VM, Daw NC, Gajjar A, Stewart CF (2006) Development and validation of limited sampling models for topotecan lactone pharmacokinetic studies in children. Cancer Chemother Pharmacol 57(4):475-482 (Pubitemid 43087590)
31. Stewart CF, Baker SD, Heideman RL, Jones D, Crom WR, Pratt CB (1994) Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity. J Clin Oncol 12(9):1946-1954 (Pubitemid 24349399)
32. D'argenio DZ, Schumitzky A (2009) ADAPT 5 user's guide: pharmacokinetic/pharmacodynamic systems analysis software. Biomedical Simulations Resource, Los Angeles
33. Mould DR, Holford NH, Schellens JH, Beijnen JH, Hutson PR, Rosing H, ten Bokkel Huinink WW, Rowinsky EK, Schiller JH, Russo M, Ross G (2002) Population pharmacokinetic and adverse event analysis of topotecan in patients with solid tumors. Clin Pharmacol Ther 71(5):334-348 (Pubitemid 34518144)
34. Dennis MJ, Beijnen JH, Grochow LB, van Warmerdam LJ (1997) An overview of the clinical pharmacology of topotecan. Semin Oncol 24(1 Suppl 5):S5
35. Matsumoto S, Yoshida K, Ishiguro N, Maeda T, Tamai I (2007) Involvement of rat and human organic anion transporter 3 in the renal tubular secretion of topotecan [(S)-9-dimethylaminomethyl-10-hydroxy-camptothecin hydrochloride]. J Pharmacol Exp Ther 322(3):1246-1252. doi:10.1124/jpet.107.123323
36. Continuous infusion topotecan with erlotinib for topotecan pretreated ovarian cancer: tumor features and phase II/pharmacokinetic evaluation (2009) OSI Pharm. http://clinicaltrials.gov/show/NCT01003938. Accessed 27 Nov 2013
37. Weroha SJ, Oberg AL, Ziegler KL, Dakhilm SR, Rowland KM, Hartmann LC, Moore DF Jr, Keeney GL, Peethambaram PP, Haluska P (2011) Phase II trial of lapatinib and topotecan (Lap-Top) in patients with platinum-refractory/resistant ovarian and primary peritoneal carcinoma. Gynecol Oncol 122(1):116-120. doi:10.1016/j.ygyno.2011.03.030
38. Lheureux S, Krieger S, Weber B, Pautier P, Fabbro M, Selle F, Bourgeois H, Petit T, Lortholary A, Plantade A, Briand M, Leconte A, Richard N, Vilquin P, Clarisse B, Blanc-Fournier C, Joly F (2012) Expected benefits of topotecan combined with lapatinib in recurrent ovarian cancer according to biological profile: a phase 2 trial. Int J Gynecol Cancer 22(9):1483-1488. doi:10.1097/IGC.0b013e31826d1438