Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

Summary

RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors. PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

Timeline

Start

2007-12-07

Primary completion

2011-12-31

Completion

2011-12-31

Outcome

Outcome not reported

Stopped: “After two years of trial initiation, only 27 out of 300 patients were included. During this period, the international recommendations for the use of COOL were modified.”

Publications

• Background Beguin Y. Prediction of response to treatment with recombinant human erythropoietin in anaemia associated with cancer. Med Oncol. 1998 Aug;15 Suppl 1:S38-46.
• Background Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur J Cancer. 2004 Oct;40(15):2201-16. doi: 10.1016/j.ejca.2004.07.015.
• Background Bonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res. 1996 Jun;5(3):309-20. doi: 10.1007/BF00433915.
• Background Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol. 1997 Jul;34(3 Suppl 2):13-9.
• Background Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.
• Background Del Mastro L, Gennari A, Donati S. Chemotherapy of non-small-cell lung cancer: role of erythropoietin in the management of anemia. Ann Oncol. 1999;10 Suppl 5:S91-4. doi: 10.1093/annonc/10.suppl_5.s91.
• Background Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998 Oct;16(10):3412-25. doi: 10.1200/JCO.1998.16.10.3412.
• Background Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol. 1997 Mar;15(3):1218-34. doi: 10.1200/JCO.1997.15.3.1218.
• Background Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst. 1999 Oct 6;91(19):1616-34. doi: 10.1093/jnci/91.19.1616.
• Background Littlewood TJ. The impact of hemoglobin levels on treatment outcomes in patients with cancer. Semin Oncol. 2001 Apr;28(2 Suppl 8):49-53. doi: 10.1016/s0093-7754(01)90213-1.
• Background Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P; European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007 Jan;43(2):258-70. doi: 10.1016/j.ejca.2006.10.014. Epub 2006 Dec 19.
• Background Aapro M, Coiffier B, Dunst J, Osterborg A, Burger HU. Effect of treatment with epoetin beta on short-term tumour progression and survival in anaemic patients with cancer: A meta-analysis. Br J Cancer. 2006 Dec 4;95(11):1467-73. doi: 10.1038/sj.bjc.6603481. Epub 2006 Nov 21.
• Background Oberhoff C. Speed of haemoglobin response in patients with cancer: a review of the erythropoietic proteins. Support Care Cancer. 2007 Jun;15(6):603-611. doi: 10.1007/s00520-006-0191-x. Epub 2007 Feb 3.
• Background Pujade-Lauraine E, Topham C. Once-weekly treatment of anemia in patients with cancer: a comparative review of epoetins. Oncology. 2005;68(2-3):122-9. doi: 10.1159/000086957. Epub 2005 Jul 7.
• Background Veys N, Dhondt A, Lameire N. Pain at the injection site of subcutaneously administered erythropoietin: phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol. 1998 Jan;49(1):41-4.
• Background Thomas ML. Impact of anemia and fatigue on quality of life in cancer patients: a brief review. Med Oncol. 1998 Aug;15 Suppl 1:S3-7.
• Background Vogelzang NJ, Breitbart W, Cella D, Curt GA, Groopman JE, Horning SJ, Itri LM, Johnson DH, Scherr SL, Portenoy RK. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol. 1997 Jul;34(3 Suppl 2):4-12.
• Background Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
• Background Harrell FE Jr, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996 Feb 28;15(4):361-87. doi: 10.1002/(SICI)1097-0258(19960229)15:43.0.CO;2-4.

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