Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-02 @ 8:21 AM
Study NCT ID:
NCT00086268
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2004-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-small Cell Lung Cancer Study US75 (Z-PACT)
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'}], '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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2004-06-29', 'studyFirstSubmitQcDate': '2004-06-30', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['lung cancer', 'ZPACT', 'US75', 'Bone Metastases'], 'conditions': ['Non Small Cell Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '19493585', 'type': 'RESULT', 'citation': 'Pandya KJ, Gajra A, Warsi GM, Argonza-Aviles E, Ericson SG, Wozniak AJ. Multicenter, randomized, phase 2 study of zoledronic acid in combination with docetaxel and carboplatin in patients with unresectable stage IIIB or stage IV non-small cell lung cancer. Lung Cancer. 2010 Mar;67(3):330-8. doi: 10.1016/j.lungcan.2009.04.020. Epub 2009 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female patients at least of 18 years old\n* Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery\n* Women must not be pregnant or attempting to become pregnant\n* Able and willing to sign informed consent\n\nExclusion Criteria:\n\n* Patients with cancer that has spread to the bone\n* Patients with cancer that has spread to the brain who are receiving treatment\n* Patients with kidney disease\n* Patients treated with other investigational drugs'}, 'identificationModule': {'nctId': 'NCT00086268', 'acronym': 'ZPACT', 'briefTitle': 'Non-small Cell Lung Cancer Study US75 (Z-PACT)', 'nctIdAliases': ['NCT00093717'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'orgStudyIdInfo': {'id': 'CZOL446EUS75'}, 'secondaryIdInfos': [{'id': 'US 75'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zometa®', 'description': '4mg monthly for 12 months from date of first chemotherapy dose', 'interventionNames': ['Drug: zoledronic acid', 'Drug: Taxotere', 'Drug: Carboplatin']}, {'type': 'NO_INTERVENTION', 'label': 'no further treatment', 'description': 'Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose'}], 'interventions': [{'name': 'zoledronic acid', 'type': 'DRUG', 'armGroupLabels': ['Zometa®']}, {'name': 'Taxotere', 'type': 'DRUG', 'armGroupLabels': ['Zometa®']}, {'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Zometa®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Consultants', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Assoc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '94533', 'city': 'Fairfield', 'state': 'California', 'country': 'United States', 'facility': 'NorthBay Cancer Center', 'geoPoint': {'lat': 38.24936, 'lon': -122.03997}}, {'zip': '91401', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials and Research Associates, Inc.', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Med. 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