Phase III, randomized, placebo-controlled study of once-daily oral zibotentan (ZD4054) in patients with non-metastatic castration-resistant prostate cancer

Prostate Cancer and Prostatic Diseases

Volumn 16, Issue 2, 2013, Pages 187-192

  Miller, K ^a   Moul, J W ^b   Gleave, M ^c   Fizazi, K ^d   Nelson, J B ^e   Morris, T ^f   Nathan, F E ^f   McIntosh, S ^f   Pemberton, K ^f   Higano, C S ^g  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^f ASTRAZENECA   (United Kingdom)

^g UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

Author keywords

castration resistant; non metastatic; ZD4054; zibotentan

Indexed keywords

PLACEBO; PROSTATE SPECIFIC ANTIGEN; ZIBOTENTAN;

ACUTE HEART FAILURE; ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CONGESTIVE HEART FAILURE; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; HEART FAILURE; HEART LEFT VENTRICLE FAILURE; HUMAN; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; NOSE OBSTRUCTION; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; RHINOPHARYNGITIS; SIDE EFFECT; THROMBOCYTE COUNT; URINARY TRACT INFECTION;

ADENOCARCINOMA; ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; EDEMA; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; PYRROLIDINES; TREATMENT OUTCOME;

EID: 84882450996     PISSN: 13657852     EISSN: 14765608     Source Type: Journal    
DOI: 10.1038/pcan.2013.2     Document Type: Article

References (28)

1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 2011; 61: 69-90.
2. Mostaghel EA, Nelson PS. Intracrine androgen metabolism in prostate cancer progression: mechanisms of castration resistance and therapeutic implications. Best Pract Res Clin Endocrinol Metab 2008; 22: 243-258. (Pubitemid 351611949)
3. Smith MR, Kabbinavar F, Saad F, Hussain A, Gittelman MC, Bilhartz DL et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol 2005; 23: 2918-2925. (Pubitemid 46224110)
4. Smith MR, Cook R, Lee KA, Nelson JB. Disease and host characteristics as predictors of time to first bone metastasis and death in men with progressive castration-resistant nonmetastatic prostate cancer. Cancer 2011; 117: 2077-2085.
5. Bagnato A, Loizidou M, Pflug BR, Curwen J, Growcott J. Role of the endothelin axis and its antagonists in the treatment of cancer. Br J Pharmacol 2011; 163: 220-233.
6. Nelson JB. Endothelin inhibition: novel therapy for prostate cancer. J Urol 2003; 170: S65-S68. (Pubitemid 37413945)
7. James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T et al. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomized, phase II trial. Eur Urol 2009; 55: 1112-1123.
8. James ND, Caty A, Payne H, Borre M, Zonnenberg BA, Beuzeboc P et al. Final safety and efficacy analysis of the specific endothelin A receptor antagonist zibotentan (ZD4054) in patients with metastatic castration-resistant prostate cancer and bone metastases who were pain-free or mildly symptomatic for pain: a double-blind, placebo-controlled, randomized phase II trial. BJU Int 2010; 106: 966-973.
9. Yu EY, Miller K, Nelson J, Gleave M, Fizazi K, Moul JW et al. Detection of previously unidentified metastatic disease as a leading cause of screening failure in a phase III trial of zibotentan versus placebo in patients with nonmetastatic, castration resistant prostate cancer. J Urol 2012; 188: 103-109.
10. Nelson JB, Fizazi K, Miller K, Higano C, Moul JW, Akaza H et al. Phase III, randomized, placebo-controlled study of zibotentan (ZD4054) in patients with castration- resistant prostate cancer metastatic to bone. Cancer 2012; 118: 5709-5718.
11. Armstrong AJ, Creel P, Turnbull J, Moore C, Jaffe TA, Haley S et al. A phase I-II study of docetaxel and atrasentan in men with castration-resistant metastatic prostate cancer. Clin Cancer Res 2008; 14: 6270-6276.
12. Banerjee S, Hussain M, Wang Z, Saliganan A, Che M, Bonfil D et al. In vitro and in vivo molecular evidence for better therapeutic efficacy of ABT-627 and taxotere combination in prostate cancer. Cancer Res 2007; 67: 3818-3826. (Pubitemid 46762169)
13. Rosano L, Di Castro V, Spinella F, Nicotra MR, Natali PG, Bagnato A. ZD4054, a specific antagonist of the endothelin A receptor, inhibits tumor growth and enhances paclitaxel activity in human ovarian carcinoma in vitro and in vivo. Mol Cancer Ther 2007; 6: 2003-2011. (Pubitemid 47052490)
14. Trump DL, Payne H, Miller K, de Bono JS, Stephenson III J, Burris III HA et al. Preliminary study of the specific endothelin a receptor antagonist zibotentan in combination with docetaxel in patients with metastatic castration-resistant prostate cancer. Prostate 2011; 71: 1264-1275.
15. Fizazi K, Higano C, Nelson J, Gleave M, Miller K, Morris T et al. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan (ZD4054) in patients with metastatic castration-resistant prostate cancer. Submitted to J Clin Oncol 2012.
16. Carducci MA, Padley RJ, Breul J, Vogelzang NJ, Zonnenberg BA, Daliani DD et al. Effect of endothelin-A receptor blockade with atrasentan on tumor progression in men with hormone-refractory prostate cancer: a randomized, phase II, placebocontrolled trial. J Clin Oncol 2003; 21: 679-689. (Pubitemid 46621903)
17. Nelson JB, Nabulsi AA, Vogelzang NJ, Breul J, Zonnenberg BA, Daliani DD et al. Suppression of prostate cancer induced bone remodeling by the endothelin receptor A antagonist atrasentan. J Urol 2003; 169: 1143-1149. (Pubitemid 36188190)
18. Carducci MA, Saad F, Abrahamsson PA, Dearnaley DP, Schulman CC, North SA et al. A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer. Cancer 2007; 110: 1959-1966. (Pubitemid 350036854)
19. Nelson JB, Love W, Chin JL, Saad F, Schulman CC, Sleep DJ et al. Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormonerefractory prostate cancer. Cancer 2008; 113: 2478-2487.
20. SWOG Press Release. Addition of atrasentan to standard chemotherapy for advanced prostate cancer shows no benefit in phase III clinical trial. SWOG 2012, Internet Communication.
21. Warren R, Liu G. ZD4054: a specific endothelin A receptor antagonist with promising activity in metastatic castration-resistant prostate cancer. Expert Opin Investig Drugs 2008; 17: 1237-1245.
22. Liu G, Dreicer R, Hou J, Chen Y, Wilding G. Tolerability profile of ZD4054 is consistent with the effects of endothelin A receptor-specific antagonism. J Clin Oncol 2005; 23: abst 4628.
23. Klabunde CN, Legler JM, Warren JL, Baldwin LM, Schrag D. A refined comorbidity measurement algorithm for claims-based studies of breast, prostate, colorectal, and lung cancer patients. Ann Epidemiol 2007; 17: 584-590. (Pubitemid 47096709)
24. Riihimaki M, Thomsen H, Brandt A, Sundquist J, Hemminki K. What do prostate cancer patients die of? Oncologist 2011; 16: 175-181.
25. Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L et al. A randomized, placebo-controlled trial of zoledronic acid in patients with hormonerefractory metastatic prostate carcinoma. J Natl Cancer Inst 2002; 94: 1458-1468.
26. Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B et al. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet 2012; 379: 39-46.
27. FDA. ODAC Briefing Document BLA 125320/28 Denosumab (Xgeva). Amgen 8 February. 2012. Available at http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM290400.pdf.
28. Adamo V, Noto L, Franchina T, Chiofalo G, Picciotto M, Toscano G et al. Emerging targeted therapies for castration-resistant prostate cancer. Front Endocrinol (Lausanne) 2012; 3: 73.