Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-30 @ 4:09 AM
Study NCT ID:
NCT00102505
Status:
COMPLETED
Last Update Posted:
2009-04-03
First Post:
2005-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D018287', 'term': 'Carcinoma, Large Cell'}], 'ancestors': [{'id': 'D001984', 'term': 'Bronchial 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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437683', 'term': 'motexafin gadolinium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2009-04-02', 'studyFirstSubmitDate': '2005-01-29', 'studyFirstSubmitQcDate': '2005-01-28', 'lastUpdatePostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin'}, {'measure': 'Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin'}], 'secondaryOutcomes': [{'measure': 'Tumor response'}]}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer', 'Lung Cancer', 'Metastatic lung cancer', 'Inoperable lung cancer', 'Advanced lung cancer', 'Large-cell lung cancer', 'Adenocarcinoma, lung', 'Squamous cell carcinoma, lung', 'Squamous cell lung cancer', 'Large cell carcinoma, lung', 'Bronchogenic'], 'conditions': ['Non-Small-Cell Lung Carcinoma', 'Carcinoma, Bronchogenic']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.\n\nA cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.\n\nEligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old\n* ECOG score of 0, 1, or 2\n* Histologically confirmed diagnosis of non-small cell lung cancer\n\nExclusion Criteria:\n\nLaboratory values demonstrating inadequate function of the following:\n\n* Bone marrow\n* Kidneys\n* Liver\n\nand\n\n* Peripheral neuropathy Grade 2 or higher\n* Greater than 2 prior chemotherapy regimens'}, 'identificationModule': {'nctId': 'NCT00102505', 'briefTitle': 'A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmacyclics LLC.'}, 'officialTitle': 'Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'PCYC-0220'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Motexafin Gadolinium Injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacyclics LLC.', 'class': 'INDUSTRY'}}}}