Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-12 @ 12:21 AM
Study NCT ID:
NCT00976456
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2009-09-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wolfgang.schuette@martha-maria.de', 'phone': '+49 345 5591440', 'title': 'Prof. Dr. Wolfgang Schuette', 'organization': 'Krankenhaus Martha-Maria Halle-Doelau gGmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bevacizumab + Pemetrexed', 'description': 'Bevacizumab + Pemetrexed\n\nBevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks', 'otherNumAtRisk': 119, 'otherNumAffected': 61, 'seriousNumAtRisk': 119, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Bevacizumab + Pemetrexed + Carboplatin', 'description': 'Bevacizumab + Pemetrexed + Carboplatin\n\nBevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks', 'otherNumAtRisk': 134, 'otherNumAffected': 97, 'seriousNumAtRisk': 134, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 83, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 146, 'numAffected': 97}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 134, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab + Pemetrexed', 'description': 'Bevacizumab + Pemetrexed\n\nBevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks'}, {'id': 'OG001', 'title': 'Bevacizumab + Pemetrexed + Carboplatin', 'description': 'Bevacizumab + Pemetrexed + Carboplatin\n\nBevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '6.0'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '7.4'}]}]}], 'analyses': [{'pValue': '0.0583', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.290', 'ciLowerLimit': '0.989', 'ciUpperLimit': '1.682', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time point.'}], 'paramType': 'MEDIAN', 'timeFrame': '42 months', 'description': 'Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab + Pemetrexed', 'description': 'Bevacizumab + Pemetrexed\n\nBevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks'}, {'id': 'OG001', 'title': 'Bevacizumab + Pemetrexed + Carboplatin', 'description': 'Bevacizumab + Pemetrexed + Carboplatin\n\nBevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '14.4'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '16.9'}]}]}], 'analyses': [{'pValue': '0.3869', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.091', 'ciLowerLimit': '0.794', 'ciUpperLimit': '1.499', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time Point.'}], 'paramType': 'MEDIAN', 'timeFrame': '42 months', 'description': 'Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bevacizumab + Pemetrexed', 'description': 'Bevacizumab + Pemetrexed\n\nBevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks'}, {'id': 'FG001', 'title': 'Bevacizumab + Pemetrexed + Carboplatin', 'description': 'Bevacizumab + Pemetrexed + Carboplatin\n\nBevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'screening failure, unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bevacizumab + Pemetrexed', 'description': 'Bevacizumab + Pemetrexed\n\nBevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks'}, {'id': 'BG001', 'title': 'Bevacizumab + Pemetrexed + Carboplatin', 'description': 'Bevacizumab + Pemetrexed + Carboplatin\n\nBevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '86'}, {'value': '72.0', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '86'}, {'value': '71.5', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '271 patients were enrolled and randomized, due to Screening failure and subject withdrawn consent the intent-to-treat (ITT) population comprised 253 evaluable patients (BP n=119; BPC n=134).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-11', 'studyFirstSubmitDate': '2009-09-11', 'resultsFirstSubmitDate': '2016-01-12', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-11', 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '42 months', 'description': 'Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '42 months', 'description': 'Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung cancer', 'NSCLC', 'elderly', 'non-squamous', 'Elderly patients at least 65 years old', 'first line therapy', 'non-squamous non-small cell lung cancer stage IIIb or IV'], 'conditions': ['Non-squamous Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Multi-center, open, randomized (parallel) and comparative phase III.\n\nEligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.\n\nArm A: Bevacizumab + pemetrexed\n\nArm B: Bevacizumab + pemetrexed + carboplatin', 'detailedDescription': "Primary:\n\n* Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(\\> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival\n\nSecondary:\n\n* To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.\n* To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.\n* To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13\n* To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment\n* To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage IIIb and IV NSCLC, excluded squamous cell NSCLC\n* Age ≥ 65 years\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component\n* History of haemoptysis\n* Evidence of tumour invading major blood vessels on imaging\n* Radiotherapy within 28 days prior to enrolment\n* Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)\n* Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed\n* Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication\n* Non-healing wound, active peptic ulcer or bone fracture\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment'}, 'identificationModule': {'nctId': 'NCT00976456', 'acronym': '65plus', 'briefTitle': 'Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Martha-Maria Krankenhaus Halle-Dölau gGmbH'}, 'officialTitle': 'Open-label Study of Bevacizumab (Avastin®) in Combination With Pemetrexed or Pemetrexed and Carboplatin as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '65 plus'}, 'secondaryIdInfos': [{'id': 'ML21896'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab + Pemetrexed', 'description': 'Bevacizumab + Pemetrexed', 'interventionNames': ['Drug: Bevacizumab + Pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab + Pemetrexed + Carboplatin', 'description': 'Bevacizumab + Pemetrexed + Carboplatin', 'interventionNames': ['Drug: Bevacizumab + Pemetrexed + Carboplatin']}], 'interventions': [{'name': 'Bevacizumab + Pemetrexed', 'type': 'DRUG', 'otherNames': ['Avastin®', 'ALIMTA®'], 'description': 'Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks', 'armGroupLabels': ['Bevacizumab + Pemetrexed']}, {'name': 'Bevacizumab + Pemetrexed + Carboplatin', 'type': 'DRUG', 'otherNames': ['Avastin®', 'ALIMTA®', 'Carboplatin'], 'description': 'Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks', 'armGroupLabels': ['Bevacizumab + Pemetrexed + Carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Krankenhaus Martha-Maria Halle-Doelau', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'overallOfficials': [{'name': 'Wolfgang Schuette, PhD MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Krankenhaus Martha-Maria Halle-Doelau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PD Dr. med. Wolfgang Schuette', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD MD', 'investigatorFullName': 'PD Dr. med. Wolfgang Schuette', 'investigatorAffiliation': 'Martha-Maria Krankenhaus Halle-Dölau gGmbH'}}}}