Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 12:30 AM
Study NCT ID:
NCT01578668
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-06-20', 'releaseDate': '2019-03-27'}], 'estimatedResultsFirstSubmitDate': '2019-03-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D010984', 'term': 'Platinum'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'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'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective response rate of brain metastases', 'timeFrame': 'Patients will be followed for an expected average of 6 weeks'}], 'secondaryOutcomes': [{'measure': 'The disease control response rate of disease', 'timeFrame': 'Patients will be followed for an expected average of 6 weeks'}, {'measure': 'Progression-free survival of patients', 'timeFrame': '2 years after first treatment'}, {'measure': 'Number of participants with adverse events as a measure of safety', 'timeFrame': '2 years after first treatment'}, {'measure': 'Overall survival of patients', 'timeFrame': '3 years after the first treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung adenocarcinoma', 'brain metastases', 'erlotinib', 'pemetrexed'], 'conditions': ['Lung Adenocarcinoma', 'Brain Metastases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.', 'detailedDescription': 'Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases\n2. 18 years or older\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)\n4. Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter \\> 5 mm by brain MRI\n5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\\^9/L, platelets 100 x 10\\^9/L\n6. Total bilirubin 1.5 x upper limit of normal (ULN)\n7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\< 2.5 x ULN in the absence of liver metastases, or \\< 5 x ULN in case of liver metastases\n8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)\n9. If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.\n\nExclusion Criteria:\n\n1. Mixed non-adenocarcinoma cell lung cancer histology\n2. Previous treatment with pemetrexed or tarceva\n3. Be allergic to pemetrexed or tarceva'}, 'identificationModule': {'nctId': 'NCT01578668', 'briefTitle': 'Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Medical University'}, 'officialTitle': 'Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases', 'orgStudyIdInfo': {'id': 'GZTO1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erlotinib, pemetrexed, cisplatin', 'interventionNames': ['Drug: erlotinib', 'Drug: pemetrexed', 'Drug: cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'erlotinib', 'interventionNames': ['Drug: erlotinib']}], 'interventions': [{'name': 'erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': '150 mg given orally (po), daily (QD), starting on the 4th day of each cycle, ending on the 21th day before the next cycle, and until disease PD', 'armGroupLabels': ['Erlotinib, pemetrexed, cisplatin']}, {'name': 'pemetrexed', 'type': 'DRUG', 'otherNames': ['ALIMTA'], 'description': '500 mg/m² intravenous (iv) over 15 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity or no more than 6 cycles', 'armGroupLabels': ['Erlotinib, pemetrexed, cisplatin']}, {'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['platinum'], 'description': 'cisplatin 20mg/m² iv on the 1st-3rd day (if PS\\<2) or 30 mg iv on the 1st-2nd day (if PS=2 or 3)of each cycle until PD or unacceptable toxicity or no more than 6 cycles', 'armGroupLabels': ['Erlotinib, pemetrexed, cisplatin']}, {'name': 'erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': '150 mg given orally (po), daily (QD), starting on the first day of the first cycle', 'armGroupLabels': ['erlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The first affiliated hospital of Guangzhou MC', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Haihong Yang, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The first affiliated hospital of Guangzhou MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The first affiliated hospital of Guangzhou MC', 'investigatorFullName': 'Haihong Yang, MD, Pricipal investigator', 'investigatorAffiliation': 'Guangzhou Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-03-27', 'type': 'RELEASE'}, {'date': '2019-06-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Haihong Yang, MD, Pricipal investigator, The first affiliated hospital of Guangzhou MC, Guangzhou Medical University'}}}}