Phase I trial of sorafenib in patients with recurrent or progressive malignant glioma

Neuro-Oncology

Volumn 13, Issue 12, 2011, Pages 1324-1330

  Nabors, L B ^a   Supko, J G ^b   Rosenfeld, M ^c   Chamberlain, M ^d   Phuphanich, S ^e   Batchelor, T ^f   Desideri, S ^f   Ye, X ^f   Wright, J ^g   Gujar, S ^g   Grossman, S A ^g  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

^e CEDARS SINAI MEDICAL CENTER   (United States)

^f NATIONAL CANCER INSTITUTE   (United States)

^g JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Angiogenesis; Glioma; Pharmacokinetics; Proliferation; Targeted therapy.

Indexed keywords

SORAFENIB;

ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; CANCER PATIENT; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GLIOMA; HAND FOOT SYNDROME; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOPHOSPHATEMIA; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; PHASE 1 CLINICAL TRIAL; PRURITUS; RECURRENT CANCER; SKIN DISEASE;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC AGENTS; BENZENESULFONATES; BRAIN NEOPLASMS; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; GLIOMA; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PYRIDINES; TISSUE DISTRIBUTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84856271656     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nor145     Document Type: Article

References (27)

1. Central Brain TumorRegistry of the United States. Statistical report: Primary brain tumors in the United States, 2000-2004; 2008. http://www.cbtrus. org/reports//2007-2008/2007report.pdf (accessed August 18, 2011).
2. Brown PD, Jensen AW, Felten SJ, et al. Detrimental effects of tumor progression on cognitive function of patients with high-grade glioma. J Clin Oncol. 2006;24:5427-5433. (Pubitemid 46623176)
3. Kvale EA, Murthy R, Taylor R, Lee JY, Nabors LB. Distress and quality of life in primary high-grade brain tumor patients. Support Care Cancer. 2009;17:793-799.
4. Laack NN, Brown PD, Ivnik RJ, et al. Cognitive function after radiotherapy for supratentorial low-grade glioma: A North Central Cancer Treatment Group prospective study. Int J Radiat Oncol Biol Phys. 2005;63:1175-1183. (Pubitemid 41505297)
5. Plate KH, Breier G, Weich HA, Risau W. Vascular endothelial growth factor is a potential tumour angiogenesis factor in human gliomas in vivo. Nature. 1992;359:845-848.
6. Vredenburgh JJ, Desjardins A, Herndon JE, 2nd, et al. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res. 2007;13:1253-1259. (Pubitemid 46424067)
7. Lama G, Mangiola A, Anile C, et al. Activated ERK1/2 expression in glioblastoma multiforme and in peritumor tissue. Int J Oncol. 2007;30:1333-1342.
8. Wilhelm S, Chien DS. BAY 43-9006: Preclinical data. Curr Pharm Des. 2002;8:2255-2257. (Pubitemid 35189898)
9. Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64:7099-7109. (Pubitemid 39331023)
10. Strumberg D, Richly H, Hilger RA, et al. Phase I clinical and pharmacokinetic study of the novel raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol. 2005;23:965-972. (Pubitemid 46202316)
11. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356:125-134. (Pubitemid 46089673)
12. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378-390.
13. Gilbert MR, Supko JG, Batchelor T, Lesser G, Fisher JD, Piantadosi S, et al. Phase I clinical trial and pharmacokinetic study of irinotecan in adult patients with recurrent malignant glioma. Clin Cancer Res. 2003;9:2940-9. (Pubitemid 37006309)
14. Gabrielsson JWD. Pharmacokinetic/Pharmacodynamic Data Analysis: Concepts and Applications. Uppsala, Sweden: Swedish Pharmaceutical Press; 1994.
15. Lacey LF, Keene ON, Pritchard JF, Bye A. Common noncompartmental pharmacokinetic variables: Are they normally or log-normally distributed? J Biopharm Stat. 1997;7:171-178. (Pubitemid 27167942)
16. Mizuta E, Tsubotani A. Preparation of mean drug concentration-time curves in plasma. A study on the frequency distribution of pharmacokinetic parameters. Chem Pharm Bull. (Tokyo). 1985;33:1620-1632. (Pubitemid 15046092)
17. Miller R. The jackknife-a review. Biometrika. 1974;61:1.
18. Strumberg D, Awada A, Hirte H, et al. Pooled safety analysis of BAY 43-9006 (sorafenib) monotherapy in patients with advanced solid tumours: Is rash associated with treatment outcome? Eur J Cancer. 2006;42:548-556. (Pubitemid 43227936)
19. Strumberg D, Voliotis D, Moeller JG, et al. Results of phase I pharmacokinetic and pharmacodynamic studies of the raf kinase inhibitor BAY 43-9006 in patients with solid tumors. Int J Clin Pharmacol Ther. 2002;40:580-581.
20. Vecht CJ, Wagner GL, Wilms EB. Interactions between antiepileptic and chemotherapeutic drugs. Lancet Neurol. 2003;2:404-409. (Pubitemid 36793932)
21. Kane RC, Farrell AT, Saber H, et al. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res. 2006;12: 7271-7278. (Pubitemid 46095398)
22. Lathia C, Lettieri J, Cihon F, Gallentine M, Radtke M, Sundaresan P. Lack of effect of ketoconazole-mediated CYP3A inhibition on sorafenib clinical pharmacokinetics. Cancer Chemother Pharmacol. 2006;57: 685-692.
23. Strumberg D, Clark JW, Awada A, et al. Safety, pharmacokinetics, and preliminary antitumor activity of sorafenib: A review of four phase I trials in patients with advanced refractory solid tumors. Oncologist. 2007;12:426-437. (Pubitemid 46698720)
24. Awada A, Hendlisz A, Gil T, et al. Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours. Br J Cancer. 2005;92: 1855-1861. (Pubitemid 40826133)
25. Clark JW, Eder JP, Ryan D, Lathia C, Lenz HJ. Safety and pharmacokinetics of the dual action raf kinase and vascular endothelial growth factor receptor inhibitor, BAY 43-9006, in patients with advanced, refractory solid tumors. Clin Cancer Res. 2005;11:5472-5480. (Pubitemid 41060823)
26. Moore M, Hirte HW, Siu L, et al. Phase I study to determine the safety and pharmacokinetics of the novel raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors. Ann Oncol. 2005;16:1688-1694. (Pubitemid 41510145)
27. Duran I, Hotte SJ, Hirte H, et al. Phase I targeted combination trial of sorafenib and erlotinib in patients with advanced solid tumors. Clin. Cancer Res. 2007;13:4849-4857. (Pubitemid 47294792)