Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 2:54 PM
Study NCT ID:
NCT00224068
Status:
COMPLETED
Last Update Posted:
2012-03-02
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035552', 'term': 'ferric gluconate'}, {'id': 'C020748', 'term': 'ferrous sulfate'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-29', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Change in various iron indices'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iron deficiency', 'Sodium ferric gluconate', 'anemia', 'cancer chemotherapy', 'epoetin alfa', 'Anemia/drug therapy', 'Anemia, Iron-Deficiency/drug therapy/etiology', 'Hematinics/administration & dosage/pharmacology', 'Antineoplastic Agents/adverse effects', 'Erythropoietin, Recombinant/therapeutic use/adverse effects'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '17296819', 'type': 'RESULT', 'citation': 'Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007 Feb;12(2):231-42. doi: 10.1634/theoncologist.12-2-231.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of nonmyeloid malignancy\n* Moderate to severe anemia\n* Adequate iron stores as measured by either TSAT or ferritin\n* About to start cycle of chemotherapy\n* Eligible for epoetin alfa therapy\n\nExclusion Criteria:\n\n* Highly elevated TSAT or ferritin\n* Recent transfusion, epoetin alfa, darbepoetin or intravenous iron\n* Medical conditions that would confound the efficacy evaluation'}, 'identificationModule': {'nctId': 'NCT00224068', 'briefTitle': 'Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Watson Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment', 'orgStudyIdInfo': {'id': 'FR01008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sodium ferric gluconate, ferrous sulfate, standard of care', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'city': 'Hutchinson', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'city': 'Greenwood', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 33.51623, 'lon': -90.17953}}, {'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'city': 'Denville', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.89232, 'lon': -74.47738}}, {'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'West Chester', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.96097, 'lon': -75.60804}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Laredo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 27.50641, 'lon': -99.50754}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'city': 'Walla Walla', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 46.06458, 'lon': -118.34302}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Naomi V. Dahl, Pharm.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Watson Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Watson Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}