Phase i trial to investigate the safety, pharmacokinetics and efficacy of sorafenib combined with docetaxel in patients with advanced refractory solid tumours

European Journal of Cancer

Volumn 48, Issue 4, 2012, Pages 465-474

  Awada, Ahmad ^a   Hendlisz, Alain ^a   Christensen, Olaf ^b   Lathia, Chetan D ^b   Bartholomeus, Sylvie ^a   Lebrun, Fabienne ^a   De Valeriola, Dominique ^a   Brendel, Erich ^c   Radtke, Martin ^c   Delaunoit, Thierry ^a   Piccart Gebhart, Martine ^a   Gil, Thierry ^a  

^a JULES BORDET INSTITUTE   (Belgium)

^b Bayer HealthCare Pharmaceuticals Inc   (United States)

^c BAYER PHARMA AG   (Germany)

Author keywords

Combination; Docetaxel; Phase I; Solid tumours; Sorafenib

Indexed keywords

DOCETAXEL; SORAFENIB;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; BONE MARROW TOXICITY; BREAST CANCER; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; HAND FOOT SYNDROME; HUMAN; INFECTION; LEUKOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; NEUROLOGIC DISEASE; NEUTROPENIA; OPEN STUDY; OUTCOME ASSESSMENT; OVARY CANCER; PAIN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; SKIN MANIFESTATION; SKIN TOXICITY; SOLID TUMOR; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; COHORT STUDIES; DISEASE PROGRESSION; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PYRIDINES; TAXOIDS; TREATMENT OUTCOME;

EID: 84857062069     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2011.12.026     Document Type: Article

References (48)

1. J.D. Hainsworth Practical aspects of weekly docetaxel administration schedules Oncologist 9 2004 538 545 (Pubitemid 39332317)
2. A. Montero, F. Fossella, G. Hortobagyi, and V. Valero Docetaxel for treatment of solid tumours: a systematic review of clinical data Lancet Oncol 6 2005 229 239 (Pubitemid 40450714)
3. F.K. Engels, A. Sparreboom, R.A. Mathot, and J. Verweij Potential for improvement of docetaxel-based chemotherapy: a pharmacological review Br J Cancer 93 2005 173 177 (Pubitemid 41133202)
4. R. Geney, M. Ungureanu, D. Li, and I. Ojima Overcoming multidrug resistance in taxane chemotherapy Clin Chem Lab Med 40 2002 918 925 (Pubitemid 35277418)
5. H. Daub, K. Specht, and A. Ullrich Strategies to overcome resistance to targeted protein kinase inhibitors Nat Rev Drug Discov 3 2004 1001 1010 (Pubitemid 39642363)
6. S.M. Wilhelm, C. Carter, and L. Tang 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 64 2004 7099 7109 (Pubitemid 39331023)
7. F. Carlomagno, S. Anaganti, and T. Guida BAY 43-9006 inhibition of oncogenic RET mutants J Natl Cancer Inst 98 2006 326 334 (Pubitemid 43338212)
8. J.B. Levy, N. Pauloski, and D. Braun Analysis of transcription and protein expression changes in the 786-O human renal cell carcinoma tumor xenograft model in response to treatment with the multi-kinase inhibitor sorafenib (BAY 43-9006) Proc Am Assoc Cancer Res 47 2006 213 214 Abstract 906
9. A. Sharma, N.R. Trivedi, and M.A. Zimmerman Mutant V599EB-Raf regulates growth and vascular development of malignant melanoma tumors Cancer Res 65 2005 2412 2421 (Pubitemid 40490153)
10. Y.S. Chang, J. Adnane, and P.A. Trail Sorafenib (BAY 43-9006) inhibits tumor growth and vascularization and induces tumor apoptosis and hypoxia in RCC xenograft models Cancer Chemother Pharmacol 59 2007 561 574 (Pubitemid 46295136)
11. Y.S. Chang, A. Henderson, and D. Xue BAY 43-9006 (Sorafenib) inhibits ectopic (s.c.) and orthotopic growth of a murine model of renal adenocarcinoma (Renca) predominantly through inhibition of tumor angiogenesis Proc Am Assoc Cancer Res 46 2005 Abstract 5831
12. M. Rahmani, E.M. Davis, and C. Bauer Apoptosis induced by the kinase inhibitor BAY 43-9006 in human leukemia cells involves down-regulation of Mcl-1 through inhibition of translation J Biol Chem 280 2005 35217 35227 (Pubitemid 41532709)
13. C. Yu, L. Bruzek, and S.H. Kaufmann The Raf kinase Inhibitor BAY 43-9006 accelerates Mcl-1 degradation and regulates pro-apoptotic function Proc Am Assoc Cancer Res 46 2005 Abstract 6155
14. B. Escudier, T. Eisen, and W.M. Stadler Sorafenib in advanced clear-cell renal-cell carcinoma N Engl J Med 356 2007 125 134 (Pubitemid 46089673)
15. J.A. McCubrey, L.S. Steelman, and S.L. Abrams Roles of the RAF/MEK/ERK and PI3K/PTEN/AKT pathways in malignant transformation and drug resistance Adv Enzyme Regul 46 2006 249 279 (Pubitemid 44301348)
16. G.K. Abou-Alfa, L. Schwartz, and S. Ricci Phase II study of sorafenib in patients with advanced hepatocellular carcinoma J Clin Oncol 24 2006 4293 4300 (Pubitemid 46630787)
17. A. Awada, A. Hendlisz, and T. Gil 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 92 2005 1855 1861 (Pubitemid 40826133)
18. J.W. Clark, J.P. Eder, and D. Ryan 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 11 2005 5472 5480 (Pubitemid 41060823)
19. T. Eisen, T. Ahmad, and K.T. Flaherty Sorafenib in advanced melanoma: a Phase II randomised discontinuation trial analysis Br J Cancer 95 2006 581 586 (Pubitemid 44325897)
20. M. Moore, H.W. Hirte, and L. Siu 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 16 2005 1688 1694 (Pubitemid 41510145)
21. M.J. Ratain, T. Eisen, and W.M. Stadler Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma J Clin Oncol 24 2006 2505 2512 (Pubitemid 46630627)
22. H. Richly, B.F. Henning, and P. Kupsch Results of a Phase I trial of sorafenib (BAY 43-9006) in combination with doxorubicin in patients with refractory solid tumors Ann Oncol 17 2006 866 873
23. J.M. Llovet, S. Ricci, and V. Mazzaferro Sorafenib in advanced hepatocellular carcinoma N Engl J Med 359 2008 378 390
24. B. Escudier, C. Szczylik, and T.E. Hutson Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma J Clin Oncol 27 2009 1280 1289
25. P. Kupsch, B.F. Henning, and K. Passarge Results of a phase I trial of sorafenib (BAY 43-9006) in combination with oxaliplatin in patients with refractory solid tumors, including colorectal cancer Clin Colorectal Cancer 5 2005 188 196
26. L.L. Siu, A. Awada, and C.H. Takimoto Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer Clin Cancer Res 12 2006 144 151 (Pubitemid 43166188)
27. B. Escudier, N. Lassau, and E. Angevin Phase I trial of sorafenib in combination with IFN alpha-2a in patients with unresectable and/or metastatic renal cell carcinoma or malignant melanoma Clin Cancer Res 13 2007 1801 1809 (Pubitemid 46952949)
28. K.T. Flaherty, M. Brose, and L. Schuchter Phase I/II trial of BAY 43-9006, carboplatin (C) and paclitaxel (P) demonstrates preliminary antitumor activity in the expansion cohort of patients with metastatic melanoma J Clin Oncol 22 2004 Abstract 7507
29. S.J. Clarke, and L.P. Rivory Clinical pharmacokinetics of docetaxel Clin Pharmacokinet 36 1999 99 114 (Pubitemid 29121684)
30. F. Marre, G.J. Sanderink, and G. de Sousa Hepatic biotransformation of docetaxel (Taxotere) in vitro: involvement of the CYP3A subfamily in humans Cancer Res 56 1996 1296 1302 (Pubitemid 26080972)
31. B.C. Goh, S.C. Lee, and L.Z. Wang Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies J Clin Oncol 20 2002 3683 3690
32. J. Hirth, P.B. Watkins, and M. Strawderman The effect of an individual's cytochrome CYP3A4 activity on docetaxel clearance Clin Cancer Res 6 2000 1255 1258 (Pubitemid 30226205)
33. N. Yamamoto, T. Tamura, and Y. Kamiya Correlation between docetaxel clearance and estimated cytochrome P450 activity by urinary metabolite of exogenous cortisol J Clin Oncol 18 2000 2301 2308 (Pubitemid 30350223)
34. K.E. Kenworthy, J.C. Bloomer, S.E. Clarke, and J.B. Houston CYP3A4 drug interactions: correlation of 10 in vitro probe substrates Br J Clin Pharmacol 48 1999 716 727 (Pubitemid 29520596)
35. Bayer HealthCare A.G. Data on file. 2006.
36. A.A. Adjei, A. Argiris, and J.R. Murren Docetaxel and irinotecan, alone and in combination, in the treatment of non-small cell lung cancer Semin Oncol 26 1999 32 40
37. V. Harvey, H. Mouridsen, and V. Semiglazov Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer J Clin Oncol 24 2006 4963 4970 (Pubitemid 46631397)
38. P.M. Ravdin, H.A. Burris III, and G. Cook Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer J Clin Oncol 13 1995 2879 2885
39. J. Tabernero, M.A. Climent, and A. Lluch A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in patients with metastatic breast cancer Ann Oncol 15 2004 1358 1365 (Pubitemid 39295024)
40. D. Strumberg, A. Awada, and H. Hirte Pooled safety analysis of BAY 43-9006 (sorafenib) monotherapy in patients with advanced solid tumours: is rash associated with treatment outcome? Eur J Cancer 42 2006 548 556 (Pubitemid 43227936)
41. L. Dal Lago, V. D'Hondt, and A. Awada Selected combination therapy with sorafenib: a review of clinical data and perspectives in advanced solid tumors Oncologist 13 2008 845 858
42. Bayer Pharmaceuticals Corp. Sorafenib (Nexavar) Nexavar (sorafenib) prescribing information. 2006.
43. T. Eisen, T. Ahmad, and M.E. Gore Phase I trial of BAY 43-9006 (sorafenib) combined with dacarbazine (DTIC) in metastatic melanoma patients J Clin Oncol 23 2005 Abstract 7508
44. D. Strumberg, H. Richly, and R.A. Hilger 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 23 2005 965 972 (Pubitemid 46202316)
45. F.K. Engels, A.J. Ten Tije, and S.D. Baker Effect of cytochrome P450 3A4 inhibition on the pharmacokinetics of docetaxel Clin Pharmacol Ther 75 2004 448 454 (Pubitemid 38534565)
46. K.T. Flaherty, M. Redlinger, and L.M. Schuchter Phase I/II, pharmacokinetic, pharmacodynamic trial of BAY 43-9006 alone in patients with metastatic melanoma J Clin Oncol 23 2005 201s Abstract 3037
47. K. Mross, S. Steinbild, and F. Baas Results from an in vitro and a clinical/pharmacological phase I study with the combination irinotecan and sorafenib Eur J Cancer 43 2007 55 63 (Pubitemid 46054474)
48. C. Kouroussis, S. Agelaki, and D. Mavroudis A dose escalation study of weekly docetaxel in patients with advanced solid tumors Cancer Chemother Pharmacol 46 2000 488 492