Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-13 @ 5:43 AM
Study NCT ID:
NCT00034606
Status:
COMPLETED
Last Update Posted:
2006-07-19
First Post:
2002-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing 3 Schedules of Alimta Plus Gemzar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 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': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2006-07-18', 'studyFirstSubmitDate': '2002-05-01', 'studyFirstSubmitQcDate': '2002-05-01', 'lastUpdatePostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Lung cancer', 'cancer', 'neoplasm', 'non-small', 'chemotherapy'], 'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Lung Neoplasms', 'Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of non-small lung cancer\n* No prior chemotherapy\n* Able to care for self\n\nExclusion Criteria:\n\n* An ongoing infection\n* Pregnancy or breast feeding\n* Other serious medical condition\n* Cancer that has spread to the brain\n* Inability to take folic acid'}, 'identificationModule': {'nctId': 'NCT00034606', 'briefTitle': 'Comparing 3 Schedules of Alimta Plus Gemzar', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'orgStudyIdInfo': {'id': '5115'}, 'secondaryIdInfos': [{'id': 'H3E-MC-JMEL'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}