Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT00701558
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2008-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
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Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Erlotinib + Gemcitabine', 'description': "Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.", 'otherNumAtRisk': 19, 'otherNumAffected': 15, 'seriousNumAtRisk': 19, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Appetite lost', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Gemcitabine', 'description': "Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death."}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of randomization until disease progression or death (up to 193 weeks)]', 'description': 'Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population included all participants who were randomized to treatment group.'}, {'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Gemcitabine', 'description': "Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death."}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of randomization until disease progression or death (up to 193 weeks)', 'description': 'Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to treatment group.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Gemcitabine', 'description': "Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death."}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of randomization until death (up to 193 weeks)', 'description': 'Overall survival was defined as the interval between the day of randomization and the date of death from any cause.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to treatment group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erlotinib + Gemcitabine', 'description': "Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Erlotinib + Gemcitabine', 'description': "Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.47', 'spread': '9.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2008-06-18', 'resultsFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-14', 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Disease Progression', 'timeFrame': 'From the time of randomization until disease progression or death (up to 193 weeks)]', 'description': 'Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'From the time of randomization until disease progression or death (up to 193 weeks)', 'description': 'Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From the time of randomization until death (up to 193 weeks)', 'description': 'Overall survival was defined as the interval between the day of randomization and the date of death from any cause.'}]}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;\n* no previous systemic chemotherapy, radiation therapy or immunotherapy;\n* Eastern Cooperative Oncology Group (ECOG) \\>=2.\n\nExclusion Criteria:\n\n* prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;\n* active, non-controlled systemic disease;\n* any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).'}, 'identificationModule': {'nctId': 'NCT00701558', 'briefTitle': 'A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'ML20951'}, 'secondaryIdInfos': [{'id': '2007-002135-83'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erlotinib + Gemcitabine', 'description': "Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.", 'interventionNames': ['Drug: Erlotinib', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': '150 mg po daily', 'armGroupLabels': ['Erlotinib + Gemcitabine']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': '1000 mg/m\\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles', 'armGroupLabels': ['Erlotinib + Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}