Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-04 @ 3:00 AM
Study NCT ID:
NCT00072059
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508420', 'term': 'continuous erythropoietin receptor activator'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-01', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-17', 'studyFirstSubmitDate': '2003-11-04', 'studyFirstSubmitQcDate': '2003-11-05', 'lastUpdatePostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-11-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['anemia', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'recurrent non-small cell lung cancer'], 'conditions': ['Anemia', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Ro 50-3821 may stimulate red blood cell production and treat anemia in patients who are receiving antineoplastic therapy for non-small cell lung cancer.\n\nPURPOSE: This randomized phase II trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage IIIB or stage IV non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the hemoglobin dose response of anemic patients with stage IIIB or IV non-small cell lung cancer receiving antineoplastic therapy treated with 6 different regimens of Ro 50-3821.\n\nSecondary\n\n* Compare the safety profile of these regimens in these patients.\n* Compare the pharmacokinetic profile of these regimens in these patients.\n* Determine additional pharmacodynamic characteristics of these regimens in these patients.\n\nOUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are randomized to 1 of 6 treatment arms. In all arms, patients begin study therapy on the first day of a course of antineoplastic therapy.\n\n* Arm I: Patients receive a lower dose of Ro 50-3821 subcutaneously (SC) once weekly.\n* Arm II: Patients receive a medium dose of Ro 50-3821 SC once weekly.\n* Arm III: Patients receive a higher dose of Ro 50-3821 SC once weekly.\n* Arm IV: Patients receive a lower dose of Ro 50-3821 SC once every 3 weeks.\n* Arm V: Patients receive a medium dose of Ro 50-3821 SC once every 3 weeks.\n* Arm VI: Patients receive a higher dose of Ro 50-3821 SC once every 3 weeks. In all arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.\n\nPatients are followed at 1 week.\n\nPROJECTED ACCRUAL: A total of 210 patients (35 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer\n\n * Stage IIIB or IV\n* Currently receiving first- or second-line antineoplastic therapy (must be scheduled to receive therapy during the 12 weeks of study therapy)\n\n * Antineoplastic therapy may include single agent or combination chemotherapy, corticosteroids, or a combination of these agents\n* Hemoglobin no greater than 11 g/dL\n\n * Transfusion independent\n* No known primary or metastatic CNS malignancy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 6 months\n\nHematopoietic\n\n* See Disease Characteristics\n* Platelet count 50,000-500,000/mm\\^3\n* No functional iron deficiency\\* (e.g., transferrin saturation less than 20% OR serum ferritin less than 100 ng/mL)\n* No known hemolysis NOTE: \\*Concurrent iron supplementation to correct deficiency allowed\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Creatinine no greater than 2.5 mg/dL\n\nCardiovascular\n\n* No clinically significant hypertension\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix\n* No acute or chronic bleeding requiring therapy within the past 3 months (e.g., patients with anemia caused by gastrointestinal bleeding)\n* No known cyanocobalamin deficiency\n* No known folic acid deficiency\n* No acute infection or inflammatory disease (C-reactive protein greater than 50 mg/L)\n* No known resistance to epoetin administration\n* No newly diagnosed (i.e., within the past 6 months) or uncontrolled epilepsy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 8 weeks since prior recombinant human erythropoietin therapy or any other erythropoiesis-stimulating drugs\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* See Disease Characteristics\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 4 weeks since prior red blood cell transfusion\n* More than 30 days since prior investigational drugs or regimens\n* No prior enrollment and randomization to this study\n* No other concurrent investigational drugs or regimens'}, 'identificationModule': {'nctId': 'NCT00072059', 'briefTitle': 'Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'An Open Label, Randomized, Multicenter, Phase II Study To Determine Hemoglobin Dose Response, Safety And Pharmacokinetic Profile Of Ro 50-3821 Given Subcutaneously Once Weekly Or Once Every 3 Weeks To Anemic Patients With Stage IIIB or IV Non-Small Cell Lung Carcinoma Receiving Antineoplastic Therapy', 'orgStudyIdInfo': {'id': 'ROCHE-NA17101'}, 'secondaryIdInfos': [{'id': 'UCLA-0303085'}, {'id': 'CDR0000335429', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'methoxy polyethylene glycol epoetin beta', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'John A. Glaspy, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}