Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00268151
Status:
TERMINATED
Last Update Posted:
2018-03-05
First Post:
2005-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer
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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'whyStopped': 'Study was terminated due to lack of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2005-12-20', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'oxaliplatin', 'capecitabine', 'XELOX-RT'], 'conditions': ['Carcinoma, Non-Small Cell Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.browncancercenter.org', 'label': 'James Graham Brown Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be safely given in combination with a low fixed dose of Capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.', 'detailedDescription': 'The purpose of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of Oxaliplatin in combination with Capecitabine and radiation in subjects with non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically proven non-small cell lung cancer\n* inoperable Stage III A or B NSCLC\n* must have measurable disease by RECIST criteria\n* no more than one prior chemotherapy for advanced disease\n* ECOG Performance Status of 0, 1, or 2\n* must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption\n* negative serum beta-HCG test and under active contraception (for females of childbearing potential)\n* no known allergies to any of the study drugs\n* willingness to sign an informed consent\n\nExclusion Criteria:\n\n* women who are pregnant or breastfeeding\n* ANC of less than 1500/mm3\n* platelet count of less than 100,000/mm3\n* estimated creatinine clearance of less than 50 cc/min (as measured by the Cockcroft-Gault equation)\n* bilirubin of less than 2mg/dl\n* SGPT of greater than 2x nl\n* peripheral neuropathy of Grade 2 or higher\n* more than one previous chemotherapy and previous radiation therapy to the chest\n* a history of CHF/MI or other significant cardiac history within the last six months'}, 'identificationModule': {'nctId': 'NCT00268151', 'briefTitle': 'Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '562.04'}, 'secondaryIdInfos': [{'id': 'OX-03-156'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG'}, {'name': 'Capecitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Goetz H Kloecker, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James Graham Brown Cancer Center/ University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'James Graham Brown Cancer Center', 'class': 'OTHER'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Goetz Kloecker', 'investigatorAffiliation': 'University of Louisville'}}}}