Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00310232
Status:
TERMINATED
Last Update Posted:
2024-04-02
First Post:
2006-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'Recommendation of DSMB for safety issue, increased mortality with study drug.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2006-03-31', 'studyFirstSubmitQcDate': '2006-03-31', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anemia and fatigue related QoL at 12 weeks following randomization', 'timeFrame': '12 weeks following randomization'}], 'secondaryOutcomes': [{'measure': 'Overall QoL and domain-specific QoL scores', 'timeFrame': '16 weeks following randomization'}, {'measure': 'hemoglobin and hematocrit levels', 'timeFrame': '6 months from randomization'}, {'measure': 'number of transfusions', 'timeFrame': '6 months from randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Quality of Life', 'Blood transfusion'], 'conditions': ['Non-Small-Cell Lung Carcinoma', 'Lung Cancer', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '17312332', 'type': 'RESULT', 'citation': 'Wright JR, Ung YC, Julian JA, Pritchard KI, Whelan TJ, Smith C, Szechtman B, Roa W, Mulroy L, Rudinskas L, Gagnon B, Okawara GS, Levine MN. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with disease-related anemia. J Clin Oncol. 2007 Mar 20;25(9):1027-32. doi: 10.1200/JCO.2006.07.1514. Epub 2007 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The general objective of this study is to improve the Quality of Life (QoL) of selected patients with advanced carcinoma of the lung. The specific objective is to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related QoL and anemia in non-small cell lung cancer patients with advanced stage disease and underlying anemia of malignancy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage III or IV, or recurrent disease; and\n2. Hemoglobin level at or below 120 g/L; and\n3. At least 18 years of age;\n\nExclusion Criteria:\n\n1. Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;\n2. Patients previously treated with high dose thoracic radiation (\\>10 fractions), or surgery, without objective evidence of disease recurrence;\n3. Planned high dose thoracic radiation therapy (\\>10 fractions);\n4. A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;\n5. Expected survival of three months or less;\n6. ECOG Performance status of 3 or 4 (see Appendix D);\n7. Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required);\n8. Blood transfusions within the last 14 days;\n9. Previous use of erythropoietin;\n10. Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);\n11. Evidence of untreated folate or vitamin B12 deficiency;\n12. History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;\n13. History of seizure disorder;\n14. Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;\n15. Pregnancy, lactation or parturition within the previous 30 days;\n16. Unwillingness or inability to complete the required QoL questionnaires;\n17. Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;\n18. Geographically inaccessible for treatment or follow-up evaluations;\n19. Currently enrolled in an ongoing therapeutic study;'}, 'identificationModule': {'nctId': 'NCT00310232', 'briefTitle': 'Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)', 'organization': {'class': 'OTHER', 'fullName': 'Ontario Clinical Oncology Group (OCOG)'}, 'officialTitle': 'Randomized Trial of Epoetin Alfa in Patients With Advanced Non-Small Cell Carcinoma of the Lung (EPO-CAN-20)', 'orgStudyIdInfo': {'id': 'CTA-Control-076080'}, 'secondaryIdInfos': [{'id': 'HC File 9427-J0921-22C'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Epoetin Alfa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Cancer Care Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'St. John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Newfoundland Cancer Treatment & Research Foundation', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Cancer Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'P3E 5J1', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northeastern Ontario Regional Cancer Centre', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Regional Cancer Centre (Juravinski)', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L2K 5K3', 'city': 'Saint Catherines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital'}, {'zip': 'M4C 3E7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto East General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Regional Cancer Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Clinical Trials Operations', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jim Wright, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hamilton Regional Cancer Centre'}, {'name': 'Mark Levine, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ontarion Clinical Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ontario Clinical Oncology Group (OCOG)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ortho Biotech, Inc.', 'class': 'INDUSTRY'}]}}}