Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-29 @ 4:06 AM
Study NCT ID:
NCT00875004
Status:
TERMINATED
Last Update Posted:
2024-06-26
First Post:
2009-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2011-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2009-04-02', 'studyFirstSubmitQcDate': '2009-04-02', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anemia', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Anemia', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '9785336', 'type': 'BACKGROUND', 'citation': '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': '15454245', 'type': 'BACKGROUND', 'citation': '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': '8763799', 'type': 'BACKGROUND', 'citation': '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': '9253779', 'type': 'BACKGROUND', 'citation': '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': '11040270', 'type': 'BACKGROUND', 'citation': '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': '10582148', 'type': 'BACKGROUND', 'citation': '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': '9779721', 'type': 'BACKGROUND', 'citation': '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': '9060566', 'type': 'BACKGROUND', 'citation': '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': '10511589', 'type': 'BACKGROUND', 'citation': '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': '11395853', 'type': 'BACKGROUND', 'citation': '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': '17182241', 'type': 'BACKGROUND', 'citation': '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': '17117175', 'type': 'BACKGROUND', 'citation': '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': '17277926', 'type': 'BACKGROUND', 'citation': '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': '16015034', 'type': 'BACKGROUND', 'citation': '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': '9491285', 'type': 'BACKGROUND', 'citation': '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': '9785330', 'type': 'BACKGROUND', 'citation': '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': '9253778', 'type': 'BACKGROUND', 'citation': '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': '9095563', 'type': 'BACKGROUND', 'citation': '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': '8668867', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Identify factors predictive of treatment failure in patients with solid tumors treated with epoetin beta while undergoing chemotherapy.\n\nSecondary\n\n* Evaluate the impact of achieving target hemoglobin levels (i.e., hemoglobin \\> 11 g/dL) after 8 weeks of treatment with epoetin beta.\n* Evaluate changes in hemoglobin levels from baseline to after 8 weeks of treatment with epoetin beta.\n* Evaluate the tolerability of epoetin beta in these patients.\n* Evaluate the quality of life of these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive epoetin beta subcutaneously once a week for ≥ 8 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients complete a quality-of-life questionnaire (FACT-An) at baseline and after 8 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Age \\> 18 years\n* Hemoglobin levels between \\[ \\> 9g/dl - \\< 11 g/dl \\] .\n* Patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol.\n* Patient with cancer undergoing chemotherapy\n* Patient without EPO within 6 months prior to current chemotherapy.\n* WHO 2 performance status (Appendix 1).\n* Patient information and signature of informed consent or legal representative\n\nExclusion criteria :\n\n* Hemoglobin \\< 9 g/dl or \\> 11 g/dl\n* Patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc…)\n* Patient with cancer treated with concomitant radiation chemotherapy.\n* Co-treated with Epo beta and scheduled transfusion prior to inclusion.\n* Hypersensitivity to the active substance or one of the NeoRecormon excipients®\n* Poorly controlled high blood pressure\n* Pregnant woman, likely to be pregnant or breastfeeding,\n* Persons deprived of liberty or under guardianship,\n* Unable to undergo medical follow-up for geographic, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT00875004', 'acronym': 'PLATON', 'briefTitle': 'Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy', 'orgStudyIdInfo': {'id': 'CDR0000633325'}, 'secondaryIdInfos': [{'id': 'CLCC-VA-2007/21'}, {'id': 'CLCC-AFSSAPS-A70755-52'}, {'id': 'INCA-RECF0639'}, {'id': 'EUDRACT-2007-003615-31'}, {'id': 'ROCHE-CLCC-PLATON'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythropoietin beta', 'interventionNames': ['Biological: epoetin beta', 'Drug: systemic chemotherapy', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'epoetin beta', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Erythropoietin beta']}, {'name': 'systemic chemotherapy', 'type': 'DRUG', 'armGroupLabels': ['Erythropoietin beta']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'armGroupLabels': ['Erythropoietin beta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Damien Pouessel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut du Cancer de Montpellier - Val d'Aurelle"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}