A phase i study of sorafenib and vorinostat in patients with advanced solid tumors with expanded cohorts in renal cell carcinoma and non-small cell lung cancer

Investigational New Drugs

Volumn 31, Issue 1, 2013, Pages 115-125

  Dasari, A ^a,d   Gore, L ^a,b   Messersmith, W A ^a   Diab, S ^a   Jimeno, A ^a   Weekes, C D ^a   Lewis, K D ^a   Drabkin, H A ^c   Flaig, T W ^a   Camidge, D R ^a  

^a UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d UNIVERSITY OF TEXAS   (United States)

Author keywords

Phase I; SAHA; Sorafenib; Vorinostat

Indexed keywords

SORAFENIB; VORINOSTAT;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTHRITIS; ARTICLE; BILE DUCT CARCINOMA; BLEEDING; CANCER COMBINATION CHEMOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL ARTICLE; COLON CANCER; COLORECTAL CANCER; CONSTIPATION; COUGHING; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; DYSPNEA; ELECTROLYTE DISTURBANCE; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLATULENCE; FLUSHING; HAND FOOT SYNDROME; HEMOPTYSIS; HOARSENESS; HUMAN; HYPERBILIRUBINEMIA; HYPERKERATOSIS; HYPERTENSION; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; KIDNEY CARCINOMA; KIDNEY SARCOMA; LEIOMYOSARCOMA; LUNG ADENOCARCINOMA; LUNG ALVEOLUS CELL CARCINOMA; LUNG NON SMALL CELL CANCER; MALE; MALLORY WEISS SYNDROME; MAXIMUM TOLERATED DOSE; MESOTHELIOMA; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL; NEUROPATHY; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; RECOMMENDED DRUG DOSE; SIDE EFFECT; SINUS CONGESTION; SOLID TUMOR; THORAX PAIN; THROMBOCYTOPENIA; WOUND HEALING IMPAIRMENT;

AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, RENAL CELL; FEMALE; HISTONE DEACETYLASE INHIBITORS; HUMANS; HYDROXAMIC ACIDS; KIDNEY NEOPLASMS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NIACINAMIDE; PHENYLUREA COMPOUNDS; PROTEIN KINASE INHIBITORS;

EID: 84873097735     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-012-9812-z     Document Type: Article

References (32)

1. Jemal A, Siegel R, Xu J, Ward E (2010) Cancer statistics, 2010. CA Cancer J Clin 60(5):277-300. doi: 10.3322/caac.20073
2. Carmeliet P, Jain RK (2011) Molecular mechanisms and clinical applications of angiogenesis. Nature 473(7347):298-307. doi: 10.1038/nature10144
3. Kaelin WG Jr (2007) The von Hippel-Lindau tumor suppressor protein and clear cell renal carcinoma. Clin Cancer Res: An Official Journal of the American Association for Cancer Research 13(2 Pt 2):680s-684s. doi: 10.1158/1078-0432. CCR-06-1865
4. Lee JT, McCubrey JA (2003) BAY-43-9006 Bayer/Onyx. Curr Opin Investig Drugs 4(6):757-763
5. Hotte SJ, Hirte HW (2002) BAY 43-9006: early clinical data in patients with advanced solid malignancies. Curr Pharm Des 8(25):2249-2253
6. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM (2009) Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol: Official Journal of the American Society of Clinical Oncology 27(20):3312-3318. doi: 10.1200/JCO.2008.19.5511
7. Korpanty G, Smyth E, Sullivan LA, Brekken RA, Carney DN (2010) Antiangiogenic therapy in lung cancer: focus on vascular endothelial growth factor pathway. Exp Biol Med (Maywood) 235(1):3-9. doi: 10.1258/ebm.2009.009191
8. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH (2006) Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355(24):2542-2550. doi: 10.1056/NEJMoa061884
9. Gridelli C, Maione P, Del Gaizo F, Colantuoni G, Guerriero C, Ferrara C, Nicolella D, Comunale D, De Vita A, Rossi A (2007) Sorafenib and sunitinib in the treatment of advanced non-small cell lung cancer. Oncologist 12(2):191-200. doi: 10.1634/theoncologist.12-2-191
10. Kramer BW, Gotz R, Rapp UR (2004) Use of mitogenic cascade blockers for treatment of C-Raf induced lung adenoma in vivo: CI-1040 strongly reduces growth and improves lung structure. BMC Cancer 4:24. doi: 10.1186/1471-2407-4-24
11. Blumenschein GR Jr, Gatzemeier U, Fossella F, Stewart DJ, Cupit L, Cihon F, O'Leary J, Reck M (2009) Phase II, multicenter, uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory, advanced non-small-cell lung cancer. J Clin Oncol: Official Journal of the American Society of Clinical Oncology 27(26):4274-4280. doi: 10.1200/JCO.2009.22.0541
12. Takimoto CH, Awada A (2008) Safety and anti-tumor activity of sorafenib (Nexavar) in combination with other anti-cancer agents: a review of clinical trials. Canc Chemother Pharmacol 61(4):535-548. doi: 10.1007/s00280-007-0639-9
13. Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M (2007) Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol: Official Journal of the American Society of Clinical Oncology 25(21):3109-3115. doi: 10.1200/JCO.2006.10.2434
14. Siegel D, Hussein M, Belani C, Robert F, Galanis E, Richon VM, Garcia-Vargas J, Sanz-Rodriguez C, Rizvi S (2009) Vorinostat in solid and hematologic malignancies. J Hematol Oncol 2:31. doi: 10.1186/1756-8722-2-31
15. Kim HJ, Bae SC (2011) Histone deacetylase inhibitors: molecular mechanisms of action and clinical trials as anti-cancer drugs. Am J Translat Res 3(2):166-179
16. Fiskus W, Ren Y, Mohapatra A, Bali P, Mandawat A, Rao R, Herger B, Yang Y, Atadja P, Wu J, Bhalla K (2007) Hydroxamic acid analogue histone deacetylase inhibitors attenuate estrogen receptor-alpha levels and transcriptional activity: a result of hyperacetylation and inhibition of chaperone function of heat shock protein 90. Clin Cancer Res: An Official Journal of the American Association for Cancer Research 13(16):4882-4890. doi: 10.1158/1078-0432.CCR-06- 3093
17. Dasmahapatra G, Yerram N, Dai Y, Dent P, Grant S (2007) Synergistic interactions between vorinostat and sorafenib in chronic myelogenous leukemia cells involve Mcl-1 and p21CIP1 down-regulation. Clin Cancer Res: An Official Journal of the American Association for Cancer Research 13(14):4280-4290. doi: 10.1158/1078-0432.CCR-07-0835
18. Zhang G, Park MA, Mitchell C, Hamed H, Rahmani M, Martin AP, Curiel DT, Yacoub A, Graf M, Lee R, Roberts JD, Fisher PB, Grant S, Dent P (2008) Vorinostat and sorafenib synergistically kill tumor cells via FLIP suppression and CD95 activation. Clin Cancer Res: An Official Journal of the American Association for Cancer Research 14(17):5385-5399. doi: 10.1158/1078-0432.CCR-08- 0469
19. Park MA, Mitchell C, Zhang G, Yacoub A, Allegood J, Haussinger D, Reinehr R, Larner A, Spiegel S, Fisher PB, Voelkel-Johnson C, Ogretmen B, Grant S, Dent P (2010) Vorinostat and sorafenib increase CD95 activation in gastrointestinal tumor cells through a Ca(2+)-de novo ceramide-PP2A-reactive oxygen species-dependent signaling pathway. Cancer Res 70(15):6313-6324. doi: 10.1158/0008-5472.CAN-10-0999
20. Walker T, Mitchell C, Park MA, Yacoub A, Graf M, Rahmani M, Houghton PJ, Voelkel-Johnson C, Grant S, Dent P (2009) Sorafenib and vorinostat kill colon cancer cells by CD95-dependent and -independent mechanisms. Mol Pharmacol 76(2):342-355. doi: 10.1124/mol.109.056523
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(3):205-216
22. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM (2007) Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356(2):125-134. doi: 10.1056/NEJMoa060655
23. Tan J, Cang S, Ma Y, Petrillo RL, Liu D (2010) Novel histone deacetylase inhibitors in clinical trials as anti-cancer agents. J Hematol Oncol 3:5. doi: 10.1186/1756-8722-3-5
24. Adjei AA, Blumenschein GR Jr, Mandrekar S, Hillman S, Gatzemeier U, Heigener D (2011) Long-term safety and tolerability of sorafenib in patients with advanced non-small-cell lung cancer: a case-based review. Clin Lung Canc 12(4):212-217. doi: 10.1016/j.cllc.2011.03.021
25. Gridelli C, Morgillo F, Favaretto A, de Marinis F, Chella A, Cerea G, Mattioli R, Tortora G, Rossi A, Fasano M, Pasello G, Ricciardi S, Maione P, Di Maio M, Ciardiello F (2011) Sorafenib in combination with erlotinib or with gemcitabine in elderly patients with advanced non-small-cell lung cancer: a randomized phase II study. Ann Oncol: Official Journal of the European Society for Medical Oncology / ESMO 22(7):1528-1534. doi: 10.1093/annonc/mdq630
26. Feldman M, van der Goot FG (2009) Novel ubiquitin-dependent quality control in the endoplasmic reticulum. Trends Cell Biol 19(8):357-363. doi: 10.1016/j.tcb.2009.05.005
27. Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF 3rd, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F (2004) Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol: Official Journal of the American Society of Clinical Oncology 22(11):2184-2191. doi: 10.1200/JCO.2004.11.022JCO.2004.11.022]
28. Wong NS, Seah EZ, Wang LZ, Yeo WL, Yap HL, Chuah B, Lim YW, Ang PC, Tai BC, Lim R, Goh BC, Lee SC (2011) Impact of UDP-gluconoryltransferase 2B17 genotype on vorinostat metabolism and clinical outcomes in Asian women with breast cancer. Pharmacogenet Genomics. doi: 10.1097/FPC.0b013e32834a8639
29. Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N (2010) Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol: Official Journal of the American Society of Clinical Oncology 28(11):1835-1842. doi: 10.1200/JCO.2009.26.1321
30. Wu S, Keresztes RS (2011) Antiangiogenic agents for the treatment of nonsmall cell lung cancer: characterizing the molecular basis for serious adverse events. Canc Investig 29(7):460-471. doi: 10.3109/07357907.2011.597815
31. Pili RL, Lodge M, Verheul H, Mashtare T, Wahl RL, Martin JE, Espinoza-Delgado I, Liu G, Carducci MA (2010) Combination of the histone deacetylase inhibitor vorinostat with bevacizumab in pre-treated patients with renal cell carcinoma: safety, efficacy and pharmacodynamic results. In: ASCO Genitourinary Cancers Symposium, San Francisco, CA, USA, 5-7 March 2010
32. Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR, Tsao A, Stewart DJ, Hicks ME, Erasmus J, Gupta S, Alden CM, Liu S, Tang X, Khuri FR, Tran HT, Johnson BE, Heymach JV, Mao L, Fossella F, Kies MS, Papadimitrakopoulou V, Davis SE, Lippman SM, Hong WK (2011) The BATTLE trial: personalizing therapy for lung cancer. Canc Discov 1(1):44-53. doi: 10.1158/2159-8274.cd-10-0010