Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

NCT00875004 | Terminated

• 6 other identifiers: CDR0000633325CLCC-VA-2007/21CLCC-AFSSAPS-A70755-52INCA-RECF0639EUDRACT-2007-003615-31ROCHE-CLCC-PLATON
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

anemia; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Treatment failure (changes in hemoglobin levels)

  The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success

  From date of randomization until the week 8

Study Arms (1)

Erythropoietin beta

EXPERIMENTAL

Biological: epoetin beta; Drug: systemic chemotherapy; Procedure: quality-of-life assessment

Interventions

epoetin beta BIOLOGICAL

Erythropoietin beta

systemic chemotherapy DRUG

Erythropoietin beta

quality-of-life assessment PROCEDURE

Erythropoietin beta

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Hemoglobin levels between \[ \> 9g/dl - \< 11 g/dl \] .
• Patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol.
• Patient with cancer undergoing chemotherapy
• Patient without EPO within 6 months prior to current chemotherapy.
• WHO 2 performance status (Appendix 1).
• Patient information and signature of informed consent or legal representative

You may not qualify if:

• Hemoglobin \< 9 g/dl or \> 11 g/dl
• Patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc…)
• Patient with cancer treated with concomitant radiation chemotherapy.
• Hypersensitivity to the active substance or one of the NeoRecormon excipients®
• Poorly controlled high blood pressure
• Pregnant woman, likely to be pregnant or breastfeeding,
• Persons deprived of liberty or under guardianship,
• Unable to undergo medical follow-up for geographic, social or psychological reasons.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (19)

• 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.

  PMID: 9785336 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.

  PMID: 15454245 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.

  PMID: 8763799 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.

  PMID: 9253779 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.

  PMID: 11040270 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.

  PMID: 10582148 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.

  PMID: 9779721 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.

  PMID: 9060566 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.

  PMID: 10511589 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.

  PMID: 11395853 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.

  PMID: 17182241 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.

  PMID: 17117175 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.

  PMID: 17277926 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.

  PMID: 16015034 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.

  PMID: 9491285 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.

  PMID: 9785330 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.

  PMID: 9253778 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.

  PMID: 9095563 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.

  PMID: 8668867 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Damien Pouessel, MD

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: December 7, 2007
• Primary Completion: December 31, 2011
• Study Completion: December 31, 2011
• Last Updated: June 26, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)