Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT00475657
Status:
TERMINATED
Last Update Posted:
2009-05-29
First Post:
2007-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
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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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'On the advice of an independent monitoring board, this trial was stopped early due to lack of efficacy of the combination pemetrexed/carboplatin for small cell lung cancer.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles', 'otherNumAffected': 5, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to measured progressive disease', 'description': 'Trial terminated - results not analyzed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to date of death from any cause', 'description': 'Trial terminated - results not analyzed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to measured progressive disease', 'description': 'Trial terminated - results not analyzed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles'}], 'paramType': 'MEAN', 'timeFrame': 'time of response to progressive disease', 'description': 'Trial terminated - results not analyzed', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stable Disease Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to measured progressive disease', 'description': 'Trial terminated - results not analyzed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pemetrexed + Cisplatin', 'description': 'Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '5.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.9', 'spread': '4.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '76.0', 'spread': '5.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Terminated due to lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-22', 'studyFirstSubmitDate': '2007-05-16', 'resultsFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2007-05-16', 'lastUpdatePostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-31', 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'baseline to measured progressive disease', 'description': 'Trial terminated - results not analyzed'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'baseline to date of death from any cause', 'description': 'Trial terminated - results not analyzed'}, {'measure': 'Progression Free Survival', 'timeFrame': 'baseline to measured progressive disease', 'description': 'Trial terminated - results not analyzed'}, {'measure': 'Duration of Response', 'timeFrame': 'time of response to progressive disease', 'description': 'Trial terminated - results not analyzed'}, {'measure': 'Stable Disease Rate', 'timeFrame': 'baseline to measured progressive disease', 'description': 'Trial terminated - results not analyzed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).\n* Functional stage from 0 to 2 of the ECOG functional scale\n* No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.\n* Previous bone marrow radiotherapy less than 25% is allowed.\n* There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.\n* Appropriate organic function.\n* Life expectancy estimated at 12 weeks minimum.\n* Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.\n* The patient must be compliant and located close to the trial area for appropriate follow-up.\n* The patient or his/her legal representative must sign an informed consent document.\n* Patients must be at least 18 years of age.\n\nExclusion Criteria:\n\n* Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.\n* Having participated in a previous pemetrexed trial.\n* Mixed histologic diagnosis of SCLC and NSCLC.\n* Concurrent illness.\n* Having an active infection.\n* Severe cardiac disease.\n* Having received recently or concurrently a vaccine against yellow fever.\n* Having suffered a previous malignant process other than SCLC.\n* Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.\n* Clinically relevant fluid accumulation in the third space.\n* Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.\n* Concurrent administration of any other anti-tumor treatment.\n* Severe renal failure.\n* Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.\n* Inability or unwillingness to take folic acid and vitamin B12 supplements.\n* Inability to take corticoids.'}, 'identificationModule': {'nctId': 'NCT00475657', 'briefTitle': 'Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '11473'}, 'secondaryIdInfos': [{'id': 'H3E-XM-S113'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: pemetrexed', 'Drug: cisplatin']}], 'interventions': [{'name': 'pemetrexed', 'type': 'DRUG', 'otherNames': ['LY231514', 'Alimta'], 'description': '500 mg/m2, intravenous (IV), every 21 days x 6 cycles', 'armGroupLabels': ['A']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': '75 mg/m2, intravenous (IV), every 21 days x 6 cycles', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15002', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15405', 'city': 'Ferrol', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'zip': '27004', 'city': 'Lugo', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '15009', 'city': 'Ourense', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '36211', 'city': 'Vigo', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}