Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 7:19 AM
Study NCT ID:
NCT00585533
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2007-12-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced 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': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wallace.akerley@hci.utah.edu', 'phone': '801-585-5986', 'title': 'Wallace Akerley, MD', 'organization': 'Huntsman Cancer Institute/University of Utah'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All participants enrolled in trial.', 'otherNumAtRisk': 40, 'otherNumAffected': 9, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival Rate at 6-months Chemotherapy-progression-free (CP-free)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants enrolled in trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '28.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants enrolled in trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000', 'lowerLimit': '48.5', 'upperLimit': '51.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'description': 'Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'All participants enrolled in trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'objective or symptomatic progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants enrolled in trial.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '10.09443', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2007-12-26', 'resultsFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-19', 'studyFirstPostDateStruct': {'date': '2008-01-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Rate at 6-months Chemotherapy-progression-free (CP-free)', 'timeFrame': '6 months', 'description': 'Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '24 months', 'description': 'Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.\n\nPatients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.', 'detailedDescription': 'Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC\n\nSecondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Performance status 0-1.\n* Weight Loss \\< 10% in preceding 3 months\n* Age 18 years and older.\n* Adjuvant chemotherapy allowed if \\> 6 months from protocol entry\n* Adequate Organ Function\n* Liver enzymes \\< 2X normal, bilirubin = normal\n* Oxygen saturation\\> 89% on room air unless chronically oxygen dependent (not cancer related)\n* Creatinine \\<2.0 mg\n\nExclusion Criteria:\n\n* Not pregnant or lactating.\n* No Clinical Brain Metastases\n* No prior chemotherapy for systemic disease\n* Imminent need for chemotherapy for impending organ dysfunction is not allowed'}, 'identificationModule': {'nctId': 'NCT00585533', 'briefTitle': 'A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer', 'nctIdAliases': ['NCT00204724'], 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'HCI12555'}, 'secondaryIdInfos': [{'id': 'IRB# 00012555'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'interventionNames': ['Drug: Erlotinib (Tarceva)']}], 'interventions': [{'name': 'Erlotinib (Tarceva)', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': 'Erlotinib', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Wallace Akerley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}