Pharmacokinetic results of a phase I trial of sorafenib in combination with dacarbazine in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 68, Issue 1, 2011, Pages 53-61

  Brendel, Erich ^a   Ludwig, Matthias ^a   Lathia, Chetan ^b   Robert, Caroline ^c,f   Ropert, Stanislas ^d   Soria, Jean Charles ^c,f   Armand, Jean Pierre ^e  

^a BAYER PHARMA AG   (Germany)

^b BAYER CORPORATION   (United States)

^c INSTITUT GUSTAVE ROUSSY   (France)

^d University Paris Descartes V ^*  (France)

^e Institut Clauidius Regaud   (France)

^f UNIVERSITÉ PARIS SACLAY   (France)

Author keywords

AIC; Dacarbazine; Pharmacokinetics; Phase I; Sorafenib

Indexed keywords

5 AMINO 4 IMIDAZOLECARBOXAMIDE; DACARBAZINE; DRUG METABOLITE; PYRAZINE DIAZOHYDROXIDE; SORAFENIB;

ADULT; ADVANCED CANCER; ALOPECIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONSTIPATION; DESQUAMATION; DIARRHEA; DRUG EFFECT; DRUG ERUPTION; DRUG EXPOSURE; DRUG HALF LIFE; FATIGUE; FEMALE; FEVER; HAND FOOT SYNDROME; HEADACHE; HUMAN; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MUCOSA INFLAMMATION; NAUSEA; NEUTROPHIL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; SOLID TUMOR; TASTE DISORDER; THROMBOCYTE; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING; WEIGHT REDUCTION;

AMINOIMIDAZOLE CARBOXAMIDE; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; DACARBAZINE; DISEASE PROGRESSION; FEMALE; HUMANS; MALE; NEOPLASMS; PROTEIN KINASE INHIBITORS; PYRIDINES;

EID: 79959586673     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-010-1423-9     Document Type: Article

References (26)

1. Wilhelm SM, Adnane L, Newell P, Villanueva A, Llovet JM, Lynch M (2008) Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling. Mol Cancer Ther 7:3129-3140
2. Wilhelm SM, Carter C, Tang L, Wilkie D, McNabola A, Rong H, Chen C, Zhang X, Vincent P, McHugh M, Cao Y, Shujath J, Gawlak S, Eveleigh D, Rowley B, Liu L, Adnane L, Lynch M, Auclair D, Taylor I, Gedrich R, Voznesensky A, Riedl B, Post LE, Bollag G, Trail PA (2004) 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 64:7099-7109 (Pubitemid 39331023)
3. Duran I, Hotte SJ, Hirte H, Chen EX, MacLean M, Turner S, Duan L, Pond GR, Lathia C, Walsh S, Wright JJ, Dancey J, Siu LL (2007) Phase I targeted combination trial of sorafenib and erlotinib in patients with advanced solid tumors. Clin Cancer Res 13:4849-4857 (Pubitemid 47294792)
4. Kupsch P, Henning BF, Passarge K, Richly H, Wiesemann K, Hilger RA, Scheulen ME, Christensen O, Brendel E, Schwartz B, Hofstra E, Voigtmann R, Seeber S, Strumberg D (2005) 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 5:188-196
5. Mross K, Steinbild S, Baas F, Gmehling D, Radtke M, Voliotis D, Brendel E, Christensen O, Unger C (2007) Results from an in vitro and a clinical/pharmacological phase I study with the combination irinotecan and sorafenib. Eur J Cancer 43:55-63 (Pubitemid 46054474)
6. Richly H, Henning BF, Kupsch P, Passarge K, Grubert M, Hilger RA, Christensen O, Brendel E, Schwartz B, Ludwig M, Flashar C, Voigtmann R, Scheulen ME, Seeber S, Strumberg D (2006) Results of a phase I trial of sorafenib (BAY 43-9006) in combination with doxorubicin in patients with refractory solid tumors. Ann Oncol 17:866-873
7. Siu LL, Awada A, Takimoto CH, Piccart M, Schwartz B, Giannaris T, Lathia C, Petrenciuc O, Moore MJ (2006) Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer. Clin Cancer Res 12:144-151 (Pubitemid 43166188)
8. Ryan CW, Goldman BH, Lara PN Jr, Mack PC, Beer TM, Tangen CM, Lemmon D, Pan CX, Drabkin HA, Crawford ED (2007) Sorafenib with interferon alfa-2b as first-line treatment of advanced renal carcinoma: a phase II study of the Southwest Oncology Group. J Clin Oncol 25:3296-3301 (Pubitemid 47325615)
9. Gollob JA, Rathmell WK, Richmond TM, Marino CB, Miller EK, Grigson G, Watkins C, Gu L, Peterson BL, Wright JJ (2007) Phase II trial of sorafenib plus interferon alfa-2b as first- or second-line therapy in patients with metastatic renal cell cancer. J Clin Oncol 25:3288-3295 (Pubitemid 47325614)
10. Escudier B, Lassau N, Angevin E, Soria JC, Chami L, Lamuraglia M, Zafarana E, Landreau V, Schwartz B, Brendel E, Armand JP, Robert C (2007) 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 13:1801-1809 (Pubitemid 46952949)
11. Adjei AA, Molina JR, Mandrekar SJ, Marks R, Reid JR, Croghan G, Hanson LJ, Jett JR, Xia C, Lathia C, Simantov R (2007) Phase I trial of sorafenib in combination with gefitinib in patients with refractory or recurrent non-small cell lung cancer. Clin Cancer Res 13:2684-2691 (Pubitemid 46788036)
12. Gridelli C, Rossi A, Mongillo F, Bareschino M, Maione P, Ciardiello F (2007) A randomized phase II study of sorafenib/gemcitabine or sorafenib/erlotinib for advanced non-small-cell lung cancer in elderly patients or patients with a performance status of 2: treatment rationale and protocol dynamics. Clin Lung Cancer 8:396-398 (Pubitemid 46918286)
13. Agarwala SS, Keilholz U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Patel K, Hauschild A (2007) Randomized phase III study of paclitaxel plus carboplatin with or without sorafenib as second-line treatment in patients with advanced melanoma [abstract]. J Clin Oncol ASCO Annual Meeting Proceedings Part I. (June 20 Supplement) 25:8510
14. McDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J, Jakub JW, Beeram M, Tarantolo S, Agarwala S, Frenette G, Puzanov I, Cranmer L, Lewis K, Kirkwood J, White JM, Xia C, Patel K, Hersh E (2008) Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol 26:2178-2185
15. Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, Minasian L, Sarosy G, Kotz HL, Premkumar A, Cao L, McNally D, Chow C, Chen HX, Wright JJ, Figg WD, Kohn EC (2008) Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol 26:3709-3714
16. Richly H, Kupsch P, Passage K, Grubert M, Hilger RA, Voigtmann R, Schwartz B, Brendel E, Christensen O, Haase CG, Strumberg D (2004) Results of a phase I trial of BAY 43-9006 in combination with doxorubicin in patients with primary hepatic cancer. Int J Clin Pharmacol Ther 42:650-651
17. Reid JM, Kuffel MJ, Miller JK, Rios R, Ames MM (1999) Metabolic activation of dacarbazine by human cytochromes P450: the role of CYP1A1, CYP1A2, and CYP2E1. Clin Cancer Res 5:2192-2197 (Pubitemid 29399277)
18. Lathia C, Lettieri J, Cihon F, Gallentine M, Radtke M, Sundaresan P (2006) Lack of effect of ketoconazole-mediated CYP3A inhibition on sorafenib clinical pharmacokinetics. Cancer Chemother Pharmacol 57:685-692
19. Eisen T, Ahmad T, Gore ME, Marais R, Gibbens I, James MG, Schwartz B, Bergamini L (2005) Phase I trial of BAY 43-9006 (sorafenib) combined with dacarbazine (DTIC) in metastatic melanoma patients [abstract]. J Clin Oncol ASCO Annual Meeting Proceedings Part I. (June 1 Supplement) 23:7508
20. Soria J, Lazar V, Lassau N, Pena C, Massard C, Robert C, Koscielny S, Deutsch E, Zafarana E, Armand JP (2007) Sorafenib (S) and dacarbazine (D) combination in patients (pts) with advanced malignant solid tumors: phase I study with tumor biopsy genomic analysis and dynamic contrast enhanced ultrasonography (DCEUS) [abstract]. J Clin Oncol ASCO Annual Meeting Proceedings Part I. (June 20 Supplement) 25:3556
21. 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
22. Ahmann DL, Bisel HF, Edmonson JH, Hahn RG, Eagan RT, O'Connell MJ, Frytak S (1976) Clinical comparison of adriamycin and a combination of methyl-CCNU and imidazole carboxamide in disseminated malignant melanoma. Clin Pharmacol Ther 19:821-824
23. Gutterman JU, Mavligit G, Gottlieb JA, Burgess MA, McBride CE, Einhorn L, Freireich EJ, Hersh EM (1974) Chemoimmunotherapy of disseminated malignant melanoma with dimethyl triazeno imidazole carboxamide and bacillus calmette-guerin. N Engl J Med 291:592-597
24. Costanza ME, Nathanson L, Schoenfeld D, Wolter J, Colsky J, Regelson W, Cunningham T, Sedransk N (1977) Results with methyl-CCNU and DTIC in metastatic melanoma. Cancer 40:1010-1015 (Pubitemid 8219451)
25. Strumberg D, Clark JW, Awada A, Moore MJ, Richly H, Hendlisz A, Hirte HW, Eder JP, Lenz HJ, Schwartz B (2007) Safety, pharmacokinetics, and preliminary antitumor activity of sorafenib: a review of four phase I trials in patients with advanced refractory solid tumors. Oncologist 12:426-437 (Pubitemid 46698720)
26. Eisen T, Marais R, Affolter A, Lorigan P, Ottensmeier C, Robert C, Corrie P, Chevreau C, Erlandsson F, Gore M, investigators Fts (2007) An open-label phase II study of sorafenib and dacarbazine as first-line therapy in patients with advanced melanoma [abstract]. J Clin Oncol ASCO Annual Meeting Proceedings Part I. (June 20 Supplement) 25:8529