Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00694603
Status:
TERMINATED
Last Update Posted:
2012-09-06
First Post:
2007-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 'D000068818', 'term': 'Cetuximab'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lvsequist@partners.org', 'phone': '617-724-4000', 'title': 'Dr. Lecia Sequist', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cetuximab', 'description': 'Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.', 'otherNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate by CT Scan Using RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab', 'description': 'Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial used a Simon two-stage design, which enrolled 18 pts in the first stage and was to proceed to enroll an additional 28 evaluable patients if 1 or more response was observed in the first group. This design provided a 57% chance of early termination if the true response rate was \\<3%. PFSand OS were calculated using the Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab', 'description': 'Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetuximab', 'description': 'Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'We recruited patients to this multicenter, single-arm, phase II clinical trial with ECOG PS 0 to 2 and advanced NSCLC who were previously treated with erlotinib or gefitinib. Patients with asymptomatic, stable CNS metastases were eligible. 18 eligible patients were enrolled in the first stage of the trial between October 2006 and March 2009.', 'preAssignmentDetails': 'All patients were required to have an available tissue sample for EGFR mutation testing, which was performed centrally at a CLIA-certified laboratory.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetuximab', 'description': 'Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', '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': 56}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2007-12-28', 'resultsFirstSubmitDate': '2012-04-28', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-02', 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate by CT Scan Using RECIST Criteria', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cetuximab', 'tyrosine kinase inhibitor'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '20975380', 'type': 'RESULT', 'citation': 'Neal JW, Heist RS, Fidias P, Temel JS, Huberman M, Marcoux JP, Muzikansky A, Lynch TJ, Sequist LV. Cetuximab monotherapy in patients with advanced non-small cell lung cancer after prior epidermal growth factor receptor tyrosine kinase inhibitor therapy. J Thorac Oncol. 2010 Nov;5(11):1855-8. doi: 10.1097/JTO.0b013e3181f0bee0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.', 'detailedDescription': '* Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects.\n* The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC\n* Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway\n* Measurable disease, as defined by RECIST criteria\n* Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable\n* Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable\n* ECOG Performance Status 0-2\n* 18 years of age or older\n* Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential\n* Bone marrow function, renal function, hepatic function as outlined in protocol\n\nExclusion Criteria:\n\n* Women who are pregnant of breastfeeding\n* Active concurrent malignancy\n* Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab\n* Significant history of uncontrolled cardiac disease\n* Uncontrolled seizure disorder, or active neurological disease\n* Prior severe infusion reactions to a monoclonal antibody\n* Prior chemotherapy regimen within 21 days prior to study entry\n* Any EGFR tyrosine kinase inhibitor within 14 days of study entry\n* Radiation therapy within 14 days prior to the first infusion of cetuximab\n* Acute hepatitis or known HIV\n* Active or uncontrolled infection\n* Any concurrent chemotherapy or any other investigational agent(s)'}, 'identificationModule': {'nctId': 'NCT00694603', 'briefTitle': 'Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway', 'orgStudyIdInfo': {'id': '06-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuximab', 'description': '400mg/m2 IV x 1 and then 250mg/m2 IV weekly', 'interventionNames': ['Drug: Cetuximab']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux'], 'description': 'Given intravenously once per week.', 'armGroupLabels': ['Cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lecia Sequist, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lecia V. Sequist', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Unity Health Toronto', 'class': 'OTHER'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Overall PI', 'investigatorFullName': 'Lecia V. Sequist', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}