Effect of Darbepoetin Alfa (Aranesp®) on Anemia in Patients With Advanced Hormone Independent Prostate Cancer

Summary

The purpose of this study is to determine whether or not Aranesp® (Darbepoetin Alfa), administered every fourth week, is effective in the treatment of blood shortage (anemia) compared to standard care of treatment (blood transfusions) in patients with anemia due to hormone refractory prostate cancer.

Timeline

Start

2006-10

Primary completion

2007-02

Completion

2007-02

Publications

• Background Aus G, Hugosson J, Norlen L. Long-term survival and mortality in prostate cancer treated with noncurative intent. J Urol. 1995 Aug;154(2 Pt 1):460-5. doi: 10.1097/00005392-199508000-00033.
• Background Potosky AL, Miller BA, Albertsen PC, Kramer BS. The role of increasing detection in the rising incidence of prostate cancer. JAMA. 1995 Feb 15;273(7):548-52.
• Background Borre M, Nerstrom B, Overgaard J. The dilemma of prostate cancer--a growing human and economic burden irrespective of treatment strategies. Acta Oncol. 1997;36(7):681-7. doi: 10.3109/02841869709001337.
• Background Brasso K, Friis S, Kjaer SK, Iversen P. [Prostatic cancer men under age 65. Occurrence and need for study]. Ugeskr Laeger. 1997 Apr 21;159(17):2543-5. Danish.
• Background Borre M, Nerstrom B, Overgaard J. The natural history of prostate carcinoma based on a Danish population treated with no intent to cure. Cancer. 1997 Sep 1;80(5):917-28.
• Background Aus G, Hugosson J, Norlen L. Need for hospital care and palliative treatment for prostate cancer treated with noncurative intent. J Urol. 1995 Aug;154(2 Pt 1):466-9. doi: 10.1097/00005392-199508000-00034.
• Background Otnes B, Harvei S, Fossa SD. The burden of prostate cancer from diagnosis until death. Br J Urol. 1995 Nov;76(5):587-94. doi: 10.1111/j.1464-410x.1995.tb07783.x.
• Background Carlsson P, Hjertberg H, Jonsson B, Varenhorst E. The cost of prostatic cancer in a defined population. Scand J Urol Nephrol. 1989;23(2):93-6. doi: 10.3109/00365598909180819.
• Background Brasso K, Friis S, Juel K, Jorgensen T, Iversen P. The need for hospital care of patients with clinically localized prostate cancer managed by noncurative intent: a population based registry study. J Urol. 2000 Apr;163(4):1150-4.
• Background Strum SB, McDermed JE, Scholz MC, Johnson H, Tisman G. Anaemia associated with androgen deprivation in patients with prostate cancer receiving combined hormone blockade. Br J Urol. 1997 Jun;79(6):933-41. doi: 10.1046/j.1464-410x.1997.00234.x.
• Background Ornstein DK, Beiser JA, Andriole GL. Anaemia in men receiving combined finasteride and flutamide therapy for advanced prostate cancer. BJU Int. 1999 Jan;83(1):43-6. doi: 10.1046/j.1464-410x.1999.00844.x.
• Background Johansson JE, Wersall P, Brandberg Y, Andersson SO, Nordstrom L; EPO-Study Group. Efficacy of epoetin beta on hemoglobin, quality of life, and transfusion needs in patients with anemia due to hormone-refractory prostate cancer--a randomized study. Scand J Urol Nephrol. 2001 Sep;35(4):288-94. doi: 10.1080/003655901750425864.
• Background Dunn A, Carter J, Carter H. Anemia at the end of life: prevalence, significance, and causes in patients receiving palliative care. J Pain Symptom Manage. 2003 Dec;26(6):1132-9. doi: 10.1016/j.jpainsymman.2003.04.001.
• Background Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):3-10. doi: 10.1054/bjoc.2001.1746.
• Background Heatherington AC, Schuller J, Mercer AJ. Pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in cancer patients: preliminary report. Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):11-6. doi: 10.1054/bjoc.2001.1747.
• Background Glaspy J, Jadeja JS, Justice G, Kessler J, Richards D, Schwartzberg L, Rigas J, Kuter D, Harmon D, Prow D, Demetri G, Gordon D, Arseneau J, Saven A, Hynes H, Boccia R, O'Byrne J, Colowick AB. A dose-finding and safety study of novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia in patients receiving multicycle chemotherapy. Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):17-23. doi: 10.1054/bjoc.2001.1748.
• Background Smith RE Jr, Tchekmedyian NS, Chan D, Meza LA, Northfelt DW, Patel R, Austin M, Colowick AB, Rossi G, Glaspy J. A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer. Br J Cancer. 2003 Jun 16;88(12):1851-8. doi: 10.1038/sj.bjc.6600994.
• Background Bohlius J, Langensiepen S, Schwarzer G, Seidenfeld J, Piper M, Bennet C, Engert A. Erythropoietin for patients with malignant disease. Cochrane Database Syst Rev. 2004;(3):CD003407. doi: 10.1002/14651858.CD003407.pub2.
• Background Bohlius J, Langensiepen S, Schwarzer G, Seidenfeld J, Piper M, Bennett C, Engert A. Recombinant human erythropoietin and overall survival in cancer patients: results of a comprehensive meta-analysis. J Natl Cancer Inst. 2005 Apr 6;97(7):489-98. doi: 10.1093/jnci/dji087.
• Background Bohlius J, Wilson J, Seidenfeld J, Piper M, Schwarzer G, Sandercock J, Trelle S, Weingart O, Bayliss S, Djulbegovic B, Bennett CL, Langensiepen S, Hyde C, Engert A. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst. 2006 May 17;98(10):708-14. doi: 10.1093/jnci/djj189.
• Background Williams KJ, Parker CA, Stratford IJ. Exogenous and endogenous markers of tumour oxygenation status: definitive markers of tumour hypoxia? Adv Exp Med Biol. 2005;566:285-94. doi: 10.1007/0-387-26206-7_38.
• Background Varlotto J, Stevenson MA. Anemia, tumor hypoxemia, and the cancer patient. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):25-36. doi: 10.1016/j.ijrobp.2005.04.049.

Drugs

Indications