Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT00083434
Status:
TERMINATED
Last Update Posted:
2011-04-27
First Post:
2004-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'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': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'whyStopped': 'This study was stopped because of an inadequate rate of enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-02'}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-25', 'studyFirstSubmitDate': '2004-05-24', 'studyFirstSubmitQcDate': '2004-05-25', 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-26', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anemia', 'Cancer'], 'conditions': ['Anemia', 'Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/scripts/cder/drugsatfda/', 'label': 'FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/'}, {'url': 'http://dailymed.nlm.nih.gov/dailymed/about.cfm', 'label': 'Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfm'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Body weight \\>/= 99lbs\n* ECOG 0-2\n* Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy\n* Screening hemoglobin level of \\</= 11.0 g/dL for men or \\</= 10.0 for women\n\nExclusion Criteria:\n\n* History of or concurrent second malignancy\n* Evidence of primary or metastatic malignancy involving the Central Nervous System'}, 'identificationModule': {'nctId': 'NCT00083434', 'briefTitle': 'Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'orgStudyIdInfo': {'id': 'CR010549'}, 'secondaryIdInfos': [{'id': 'EPO-CAN-303'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Epoetin alfa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Urology Medical Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Shapiro, Stafford & Yee', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Tukoi Research', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hanover Medical Specialists, PA', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '98431-5000', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center Urology Services', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}}}}