Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT00061451
Status:
COMPLETED
Last Update Posted:
2010-12-22
First Post:
2003-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-20', 'studyFirstSubmitDate': '2003-05-28', 'studyFirstSubmitQcDate': '2003-05-28', 'lastUpdatePostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.'}], 'secondaryOutcomes': [{'measure': 'To assess time to objective tumor response for responding patients'}, {'measure': 'To assess duration of response for responding patients'}, {'measure': 'To assess time to treatment failure for patients'}, {'measure': 'To assess progression free survival of patients'}, {'measure': 'To assess time to progressive disease for patients'}, {'measure': 'To assess survival time for patients'}, {'measure': 'To characterize the toxicities of gemcitabine plus pemetrexed in this patient population'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine:\n\n1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.\n2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.\n3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.\n4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy.\n* Have received no prior chemotherapy for Non-Small Cell Lung Cancer.\n* Have at least one measurable lesion.\n* Have an adequate performance status.\n* Sign an informed consent.\n\nExclusion Criteria:\n\n* A female who is pregnant or breastfeeding.\n* Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.\n* Treatment with radiation therapy within the last 4 weeks.\n* Brain metastasis that is uncontrolled.\n* Active infection or other serious condition.'}, 'identificationModule': {'nctId': 'NCT00061451', 'briefTitle': 'Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial', 'orgStudyIdInfo': {'id': '7213'}, 'secondaryIdInfos': [{'id': 'H3E-US-JMFY'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG'}, {'name': 'Gemcitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 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': 37.44188, 'lon': -122.14302}}, {'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 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': 38.95171, 'lon': -92.33407}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 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': 39.09973, 'lon': -94.57857}}, {'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 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': 47.60621, 'lon': -122.33207}}], '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'}}}}