Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-03-09 @ 10:42 PM
Study NCT ID:
NCT01058759
Status:
TERMINATED
Last Update Posted:
2018-08-22
First Post:
2010-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taxotere-Enoxaparin-(ENOXA)-Study
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': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2010-01-28', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progressive free survival', 'timeFrame': 'monthly'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'monthly'}, {'measure': 'RECIST', 'timeFrame': 'monthly'}, {'measure': 'Quality of life', 'timeFrame': 'every three months'}, {'measure': 'thromboembolic complications', 'timeFrame': 'monthly'}, {'measure': 'safety of long term application of Enoxaparin', 'timeFrame': 'monthly'}, {'measure': 'overall toxicity', 'timeFrame': 'monthly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'NSCLC', 'Enoxaparin', 'Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Men and women aged 18 and older\n* Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy\n* Life expectancy at least 12 weeks\n* EOCG performance \\< 1\n* Appropriate renal and hepatic function\n* Appropriate Hematology\n* No bleeding events within 4 weeks prior to randomization\n* No indication for prophylactic or therapeutic anticoagulation therapy\n* Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization\n* Capability for s.c. injection of Enoxaparin every 24 hrs\n\nExclusion Criteria:\n\n* History of cancer other than NSCLC\n* Known contraindication for Enoxaparin e.g. HIT,\n* Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication\n* Participation in any other clinical trials within 30 days prior to randomization\n* Any known medical condition that does not allow therapy according to study protocol\n* Seizure disorder'}, 'identificationModule': {'nctId': 'NCT01058759', 'briefTitle': 'Taxotere-Enoxaparin-(ENOXA)-Study', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as Single Therapy or in Combination With Enoxaparin in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, a Phase III Study', 'orgStudyIdInfo': {'id': 'ENOXA-NSCLC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm B: Enoxaparin', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: No Enoxaparin', 'interventionNames': ['Other: No Enoxaparin']}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'armGroupLabels': ['Arm B: Enoxaparin']}, {'name': 'No Enoxaparin', 'type': 'OTHER', 'armGroupLabels': ['Arm A: No Enoxaparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxonia', 'country': 'Germany', 'facility': 'Hannover Medical School, Department of Pneumology', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Nicolas Dickgreber, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}