Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-20 @ 7:55 AM
Study NCT ID:
NCT00404703
Status:
TERMINATED
Last Update Posted:
2016-08-24
First Post:
2006-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D017671', 'term': 'Platinum Compounds'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'whyStopped': 'Primary (safety) endpoint reached', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2006-11-28', 'studyFirstSubmitQcDate': '2006-11-28', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of grade >=3 Avastin-related pulmonary hemorrhage', 'timeFrame': 'After a maximum of 12 months treatment'}], 'secondaryOutcomes': [{'measure': 'Overall response, duration of response, progression-free survival.', 'timeFrame': 'Event driven'}, {'measure': 'AEs, laboratory parameters, coagulation parameters.', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* documented squamous non-small cell lung cancer;\n* stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;\n* suitable for platinum-based treatment as first line chemotherapy.\n\nExclusion Criteria:\n\n* prior systemic anti-tumor therapy;\n* prior radiotherapy for treatment of patient's current stage of disease;\n* other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;\n* major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization."}, 'identificationModule': {'nctId': 'NCT00404703', 'briefTitle': 'A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage', 'orgStudyIdInfo': {'id': 'BO19734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: bevacizumab [Avastin]', 'Drug: Platinum-based chemotherapy']}], 'interventions': [{'name': 'bevacizumab [Avastin]', 'type': 'DRUG', 'description': '15mg iv on day 1 of each 3 week cycle', 'armGroupLabels': ['1']}, {'name': 'Platinum-based chemotherapy', 'type': 'DRUG', 'description': 'As prescribed', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tugun', 'country': 'Australia', 'geoPoint': {'lat': -28.15, 'lon': 153.5}}, {'city': 'Wollongong', 'country': 'Australia', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Ostrava', 'country': 'Czechia', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Ústí nad Labem', 'country': 'Czechia', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Bobigny', 'country': 'France', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Székesfehérvár', 'country': 'Hungary', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'city': 'Szombathely', 'country': 'Hungary', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'city': 'Kfar Saba', 'country': 'Israel', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Ramat Gan', 'country': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Balashikha', 'country': 'Russia', 'geoPoint': {'lat': 55.79479, 'lon': 37.94794}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Seville', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Kueishan', 'country': 'Taiwan'}, {'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}