Phase I dose-finding and pharmacokinetic study of the oral epidermal growth factor receptor tyrosine kinase inhibitor Ro50-8231 (erlotinib) in Japanese patients with solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 61, Issue 3, 2008, Pages 489-496

  Yamamoto, Noboru ^a   Horiike, Atsushi ^a   Fujisaka, Yasuhito ^a   Murakami, Haruyasu ^a   Shimoyama, Tatsu ^a   Yamada, Yasuhide ^a   Tamura, Tomohide ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

Author keywords

EGFR; Erlotinib; Phase I study; Ro50 8231; Tarceva; Tyrosine kinase inhibitor

Indexed keywords

CISPLATIN; DRUG METABOLITE; ERLOTINIB; IRINOTECAN; METHYLPREDNISOLONE; MINOCYCLINE; OSI 420; PREDNISOLONE; PYRIDOXINE; RIBOFLAVIN; RO 50 8231; UNCLASSIFIED DRUG;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CORNEA EROSION; DIARRHEA; DRUG ACCUMULATION; DRUG DOSE ESCALATION; DRUG ERUPTION; DRUG HALF LIFE; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEAD AND NECK CANCER; HUMAN; INTERSTITIAL PNEUMONIA; JAPANESE; KERATITIS; LEUKOPENIA; LIVER DYSFUNCTION; LUNG NON SMALL CELL CANCER; MALE; MORNING DOSAGE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RECOMMENDED DRUG DOSE; SEBORRHEA; SIDE EFFECT; SINGLE DRUG DOSE; STOMATITIS; TREATMENT RESPONSE;

ADULT; AGED; AREA UNDER CURVE; CARCINOMA, NON-SMALL-CELL LUNG; DOSE-RESPONSE RELATIONSHIP, DRUG; ENZYME INHIBITORS; FEMALE; FOLLOW-UP STUDIES; HALF-LIFE; HUMANS; JAPAN; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASMS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 37249041552     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-007-0494-8     Document Type: Article

References (27)

1. Akita RW, Sliwkowski MX (2003) Preclinical studies with erlotinib (Tarceva). Semin Oncol 30:15-24
2. Bence AK, Anderson EB, Halepota MA, Doukas MA, DeSimone PA, Davis GA, Smith DA, Koch KM, Stead AG, Mangum S, Bowen CJ, Spector NL, Hsieh S, Adams VR (2005) Phase I pharmacokinetic studies evaluating single and multiple doses of oral GW572016, a dual EGFR-ErbB2 inhibitor, in healthy subjects. Invest New Drugs 23:39-49
3. Bonomi P (2003) Clinical studies with non-iressa EGFR tyrosine kinase inhibitors. Lung Cancer 41(1):S43-S48
4. Bulgaru AM, Mani S, Goel S, Perez-Solar R (2003) Erlotinib (Tarceva): a promising drug targeting epidermal growth factor receptor tyrosine kinase. Expert Rev Anticancer Ther 3:269-279
5. Carpenter G, Cohen S (1990) Epidermal growth factor. J Biol Chem 265:7709-7712
6. Faber MS, Fuhr U (2004) Time response of cytochrome P450 1A2 activity on cessation of heavy smoking. Clin Pharmacol Ther 76:178-184
7. Giaccone G (2005) HER1/EGFR targeted agents: predicting the future for patients with unpredictable outcomes to therapy. Ann Oncol 16:538-548
8. Hamilton M, Wolf JL, Rusk J, Beard SE, Clark GM, Witt K, Cagnoni PJ (2006) Effects of smoking on the pharmacokinetics of erlotinib. Clin Cancer Res 12:2166-2171
9. Hidalgo M (2003) Erlotinib: preclinical investigations. Oncology (Huntingt) 17:11-16
10. Hidalgo M, Siu LL, Nemunaitis J, Rizzo J, Hammond LA, Takimoto C, Eckhardt SG, Tolcher A, Britten CD, Denis L, Ferrante K, Von Hoff DD, Silberman S, Rowinsky EK (2001) Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J Clin Oncol 19:3267-3279
11. Inoue A, Saijo Y, Maemondo M, Gomi K, Tokue Y, Kimura Y, Ebina M, Kikuchi T, Moriya T, Nukiwa T (2003) Severe acute interstitial pneumonia and gefitinib. Lancet 361:137-139
12. Jorissen RN, Walker F, Pouliot N, Garrett TP, Ward CW, Burgess AW (2003) Epidermal growth factor receptor: mechanisms of activation and signalling. Exp Cell Res 284:31-53
13. Kosaka T, Yatabe Y, Endoh H, Kuwano H, Takahashi T, Mitsudomi T (2004) Mutations of the epidermal growth factor receptor gene in lung cancer: biological and clinical implications. Cancer Res 64:8919-8923
14. Lepper ER, Swain SM, Tan AR, Figg WD, Sparreboom A (2003) Liquid-chromatographic determination of erlotinib (OSI-774), an epidermal growth factor receptor tyrosine kinase inhibitor. J Chromatogr B Analyt Technol Biomed Life Sci 796:181-188
15. Nakagawa K, Tamura T, Negoro S, Kudoh S, Yamamoto N, Yamamoto N, Takeda K, Swaisland H, Nakatani I, Hirose M, Dong RP, Fukuoka M (2003) Phase I pharmacokinetic trial of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor gefitinib ('Iressa', ZD1839) in Japanese patients with solid malignant tumors. Ann Oncol 14:922-930
16. Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M (2004) EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304:1497-1500
17. Pao W, Miller V, Zakowski M, Doherty J, Politi K, Sarkaria I, Singh B, Heelan R, Rusch V, Fulton L, Mardis E, Kupfer D, Wilson R, Kris M, Varmus H (2004) EGF receptor gene mutations are common in lung cancers from "never smokers" and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci USA 101:13306-13311
18. Perez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara P, Bonomi P (2004) Determinants of tumor response and survival with erlotinib in patients with non-small-cell lung cancer. J Clin Oncol 22:3238-3247
19. 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, National Cancer Institute of Canada Clinical Trials Group (2005) Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132
20. Shigematsu H, Lin L, Takahashi T, Nomura M, Suzuki M, Wistuba II, Fong KM, Lee H, Toyooka S, Shimizu N, Fujisawa T, Feng Z, Roth JA, Herz J, Minna JD, Gazdar AF (2005) Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst 97:339-346
21. Sridhar SS, Seymour L, Shepherd FA (2003) Inhibitors of epidermal-growth-factor receptors: a review of clinical research with a focus on non-small-cell lung cancer. Lancet Oncol 4:397-406
22. Takano T, Ohe Y, Kusumoto M, Tateishi U, Yamamoto S, Nokihara H, Yamamoto N, Sekine I, Kunitoh H, Tamura T, Kodama T, Saijo N (2004) Risk factors for interstitial lung disease and predictive factors for tumor response in patients with advanced non-small cell lung cancer treated with gefitinib. Lung Cancer 45:93-104
23. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) 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 92:205-216
24. Tsao MS, Kamel-Reid S, Shepherd FA (2006) Assessing EGFR mutations. N Engl J Med 354:527-528
25. Tsao MS, Sakurada A, Cutz JC, Zhu CQ, Kamel-Reid S, Squire J, Lorimer I, Zhang T, Liu N, Daneshmand M, Marrano P, da Cunha Santos G, Lagarde A, Richardson F, Seymour L, Whitehead M, Ding K, Pater J, Shepherd FA (2005) Erlotinib in lung cancer-molecular and clinical predictors of outcome. N Engl J Med 353:133-144
26. Wikstrand CJ, Bigner DD (1998) Prognostic applications of the epidermal growth factor receptor and its ligand, transforming growth factor-alpha. J Natl Cancer Inst 90:799-801
27. Yoshida S (2005) The results of gefitinib prospective investigation. Med Drug J 41:772-789