Clinical trial · Interventional
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy
NCT00875004CI-TRIAL-00078306PLATONterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin beta | Biological | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erythropoietin beta
- interventionNames
- Biological: epoetin beta
- Drug: systemic chemotherapy
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Treatment failure (changes in hemoglobin levels)
- timeFrame
- From date of randomization until the week 8
- description
- The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion criteria : * 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 Exclusion criteria : * 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. * Co-treated with Epo beta and scheduled transfusion prior to inclusion. * 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.
References
Publications (19)
- BACKGROUNDBeguin 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
- BACKGROUNDBokemeyer 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
- BACKGROUNDBonomi 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
- BACKGROUNDCella 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
- BACKGROUNDCurt 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
- BACKGROUNDDel 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
- BACKGROUNDDemetri 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.