Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT01189435
Status:
TERMINATED
Last Update Posted:
2015-11-18
First Post:
2010-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'rielyg@mskcc.org', 'phone': '646-888-4199', 'title': 'Dr. Gregory Riely', 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Erlotinib', 'description': 'This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.\n\nerlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-3.0'}, {'term': 'Glucose, high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-3.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib', 'description': 'This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.\n\nerlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.'}], 'timeFrame': '2 years', 'description': 'in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erlotinib', 'description': 'This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.\n\nerlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Erlotinib', 'description': 'This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.\n\nerlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', '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': 2}}, 'statusModule': {'whyStopped': 'Lack of accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-17', 'studyFirstSubmitDate': '2010-08-25', 'resultsFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-07', 'studyFirstPostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib', 'timeFrame': '2 years', 'description': 'in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OSI-774, TARCEVA (ERLOTINIB)', 'Lung', 'recurrent', '10-097', 'Gefitinib'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A history of stage I-IIIB NSCLC\n* Previously underdone definitive surgery or radiation\n* Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time\n* Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence\n* Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor\n* Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)\n* Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field\n* Signed informed consent\n* Age \\> or = to 21 years old\n* Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped\n\nExclusion Criteria:\n\n* Prior progressive disease while receiving erlotinib or gefitinib therapy\n* Patients with known pre-existing interstitial lung disease\n* Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome\n* AST or ALT greater than five times the upper limit of normal\n* Pregnant or lactating women\n* Medically unfit for erlotinib therapy as determined by treating oncologist"}, 'identificationModule': {'nctId': 'NCT01189435', 'briefTitle': 'Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib', 'orgStudyIdInfo': {'id': '10-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'erlotinib', 'description': 'This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.', 'interventionNames': ['Drug: erlotinib']}], 'interventions': [{'name': 'erlotinib', 'type': 'DRUG', 'description': 'After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.', 'armGroupLabels': ['erlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Christopher Azzoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}