A phase II study of sorafenib in combination with bicalutamide in patients with chemotherapy-naïve castration resistant prostate cancer

Investigational New Drugs

Volumn 30, Issue 4, 2012, Pages 1652-1659

  Beardsley, Emma K ^a   Hotte, Sebastien J ^b   North, Scott ^c   Ellard, Susan L ^a   Winquist, Eric ^d   Kollmannsberger, Christian ^a   Mukherjee, Som D ^b   Chi, Kim N ^a  

^a BRITISH COLUMBIA CANCER AGENCY   (Canada)

^b JURAVINSKI CANCER CENTRE   (Canada)

^c CROSS CANCER INSTITUTE   (Canada)

^d LONDON HEALTH SCIENCES CENTRE   (Canada)

Author keywords

Bicalutamide; Phase II clinical trial; Prostate cancer; Sorafenib

Indexed keywords

ANTIANDROGEN; BICALUTAMIDE; PROSTATE SPECIFIC ANTIGEN; SORAFENIB;

ADULT; AGED; ALOPECIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER CHEMOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG TREATMENT FAILURE; DRUG USE; DRUG WITHDRAWAL; DYSARTHRIA; DYSGEUSIA; DYSPEPSIA; DYSPNEA; ERYTHEMA MULTIFORME; FATIGUE; FLUSHING; HAND FOOT SYNDROME; HEARTBURN; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOKALEMIA; INFECTION; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE WEAKNESS; NAUSEA; OVERALL SURVIVAL; PAIN; PANCREATITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; TREATMENT RESPONSE; WEIGHT REDUCTION;

AGED; AGED, 80 AND OVER; ANILIDES; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NITRILES; ORCHIECTOMY; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; PYRIDINES; TIME FACTORS; TOSYL COMPOUNDS; TREATMENT FAILURE;

EID: 84862680747     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-011-9722-5     Document Type: Article

References (27)

1. Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA (2004) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512
2. Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L, Chin JL, Vinholes JJ, Goas JA, Chen B (2002) A randomized, placebo-controlled trial of zoledronic acid in patients with hormone-refractory metastatic prostate carcinoma. J Natl Cancer Inst 94:1458-1468
3. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF (2010) Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 363:411-422
4. Kucuk O, Fisher E, Moinpour CM, Coleman D, Hussain MH, Sartor AO, Chatta GS, Lowe BA, Eisenberger MA, Crawford ED (2001) Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed: a Southwest Oncology Group study (SWOG 9235). Urology 58:53-58
5. Fossa SD, Slee PH, Brausi M, Horenblas S, Hall RR, Hetherington JW, Aaronson N, de Prijck L, Collette L (2001) Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European organization for research and treatment of cancer genitourinary group. J Clin Oncol 19:62-71
6. Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, Gable P, Torti FM, Kaplan E, Vogelzang NJ (2004) Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol 22:1025-1033
7. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI (2011) Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 364:1995-2005
8. Feldman BJ, Feldman D (2001) The development of androgenindependent prostate cancer. Nat Rev Cancer 1:34-45
9. Palanisamy N, Ateeq B, Kalyana-Sundaram S, Pflueger D, Ramnarayanan K, Shankar S, Han B, Cao Q, Cao X, Suleman K, Kumar-Sinha C, Dhanasekaran SM, Chen YB, Esgueva R, Banerjee S, LaFargue CJ, Siddiqui J, Demichelis F, Moeller P, Bismar TA, Kuefer R, Fullen DR, Johnson TM, Greenson JK, Giordano TJ, Tan P, Tomlins SA, Varambally S, Rubin MA, Maher CA, Chinnaiyan AM (2010) Rearrangements of the RAF kinase pathway in prostate cancer, gastric cancer and melanoma. Nat Med 16:793-798
10. Taylor BS, Schultz N, Hieronymus H, Gopalan A, Xiao Y, Carver BS, Arora VK, Kaushik P, Cerami E, Reva B, Antipin Y, Mitsiades N, Landers T, Dolgalev I, Major JE, Wilson M, Socci ND, Lash AE, Heguy A, Eastham JA, Scher HI, Reuter VE, Scardino PT, Sander C, Sawyers CL, Gerald WL (2010) Integrative genomic profiling of human prostate cancer. Cancer Cell 18(1):11-22
11. Huss WJ, Hanrahan CF, Barrios RJ, Simons JW, Greenberg NM (2001) Angiogenesis and prostate cancer: identification of a molecular progression switch. Cancer Res 61:2736-2743
12. Sweeney P, Karashima T, Kim SJ, Kedar D, Mian B, Huang S, Baker C, Fan Z, Hicklin DJ, Pettaway CA, Dinney CP (2002) Anti-vascular endothelial growth factor receptor 2 antibody reduces tumorigenicity and metastasis in orthotopic prostate cancer xenografts via induction of endothelial cell apoptosis and reduction of endothelial cell matrix metalloproteinase type 9 production. Clin Cancer Res 8:2714-2724
13. George DJ, Halabi S, Shepard TF, Vogelzang NJ, Hayes DF, Small EJ, Kantoff PW (2001) Prognostic significance of plasma vascular endothelial growth factor levels in patients with hormonerefractory prostate cancer treated on Cancer and Leukemia Group B 9480. Clin Cancer Res 7:1932-1936
14. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J (2008) Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359:378-390
15. 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 356:125-134
16. Chi KN, Ellard SL, Hotte SJ, Czaykowski P, Moore M, Ruether JD, Schell AJ, Taylor S, Hansen C, Gauthier I, Walsh W, Seymour L (2008) A phase II study of sorafenib in patients with chemo-naive castration-resistant prostate cancer. Ann Oncol 19:746-751
17. Dahut WL, Scripture C, Posadas E, Jain L, Gulley JL, Arlen PM, Wright JJ, Yu Y, Cao L, Steinberg SM, Aragon-Ching JB, Venitz J, Jones E, Chen CC, Figg WD (2008) A phase II clinical trial of sorafenib in androgen-independent prostate cancer. Clin Cancer Res 14:209-214
18. Bakin RE, Gioeli D, Bissonette EA, Weber MJ (2003) Attenuation of Ras signaling restores androgen sensitivity to hormone-refractory C4-2 prostate cancer cells. Cancer Res 63:1975-1980
19. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1-10
20. Bubley GJ, Carducci M, Dahut W, Dawson N, Daliani D, Eisenberger M, Figg WD, Freidlin B, Halabi S, Hudes G, Hussain M, Kaplan R, Myers C, Oh W, Petrylak DP, Reed E, Roth B, Sartor O, Scher H, Simons J, Sinibaldi V, Small EJ, Smith MR, Trump DL, Wilding G et al (1999) Eligibility and response guidelines for phase II clinical trials in androgenindependent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 17:3461-3467
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. Joyce R, Fenton MA, Rode P, Constantine M, Gaynes L, Kolvenbag G, DeWolf W, Balk S, Taplin ME, Bubley GJ (1998) High dose bicalutamide for androgen independent prostate cancer: effect of prior hormonal therapy. J Urol 159:149-153
23. Suzuki H, Okihara K, Miyake H, Fujisawa M, Miyoshi S, Matsumoto T, Fujii M, Takihana Y, Usui T, Matsuda T, Ozono S, Kumon H, Ichikawa T, Miki T (2008) Alternative nonsteroidal antiandrogen therapy for advanced prostate cancer that relapsed after initial maximum androgen blockade. J Urol 180:921-927
24. Smith DC, Spira A, Grève JD, Hart L, Holbrechts S, Lin CC, Hussain M, Herrick S, Houggy K, Vogelzang N (2010) Phase 2 study of XL184 in a cohort of patients (pts) with castration resistant prostate cancer (CRPC) and measurable soft tissue disease. 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Berlin, Germany (16-19 November 2010): Abstract 406
25. Olsson A, Bjork A, Vallon-Christersson J, Isaacs JT, Leanderson T Tasquinimod (ABR-215050), a quinoline-3-carboxamide antiangiogenic agent, modulates the expression of thrombospondin-1 in human prostate tumors. Mol Cancer 9:107
26. Pili R, Haggman M, Stadler WM, Gingrich JR, Assikis VJ, Björk A, Forsberg G, Carducci MA, Armstrong AJ (2010) A randomized, multicenter, international phase II study of tasquinimod in chemotherapy naïve patients with metastatic castrate-resistant prostate cancer (CRPC). J Clin Oncol 28(15s): Abstract 4510
27. Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL (2010) Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet 375:1437-1446